Antigentests Übersicht BfArM

Liste der Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2, die Gegenstand des Anspruchs nach § 1 Satz 1 gemäß "Dritte Verordnung zur Änderung der Verordnung zum Anspruch auf bestimmte Testungen für den Nachweis des Vorliegens einer Infektion mit dem Coronavirus SARS-CoV-2 (Coronavirus-Testverordnung – TestV)" sind.

                             

Quelle: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)                                                     

                             

Stand 30.10.2020                            

                             

Alle Daten gemäß Übermittlung des Herstellers, verbindlich sind ausschließlich die Angaben in den jeweiligen Gebrauchsinformationen.  


Alphabetisch sortiert ("Hersteller Name")

Hersteller Name Hersteller Stadt Hersteller Land Deutsche/r Vertreiber EU Bevollmächtigter Name EU Bevollmächtigter Stadt EU Bevollmächtigter Land Handelsname des Tests Artikelnummer Sensitivität % 95%iges Vertrauensintervall (Sensitivität) Spezifität % 95%iges Vertrauensintervall (Spezifität) Gebrauchsanweisung
Abbott Rapid Diagnostics Jena GmbH Jena DE Abbott Rapid Diagnostics Germany GmbH       Panbio™ COVID-19 Ag Rapid Test Device 41FK10 91,4 85,5 - 95,5 99,8 98,8 - 100 https://ensur.invmed.com/ensur/contentAction.aspx?key=ensur.547995.S2R4E4A3.20201014.11230.4318006
Acro Biotech Inc. Rancho Cucamonga US Aidian Germany GmbH MedNet GmbH Münster DE Acro COVID-19 and Influenza A+B Antigen Combo Rapid Test ICIC-ACO525 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300304_ICIC-525_ACRO_CE_EN_PI.pdf
Acro Biotech Inc. Rancho Cucamonga US Aidian Germany GmbH MedNet GmbH Münster DE Acro COVID-19 Antigen Rapid Test INCP-ACO502 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300204_ICOV-502_ACRO_CE_EN_PI.pdf
AMEDA Labordiagnostik GmbH Graz AT DIM LabService GmbH & Co. KG       AMP Rapid Test SARS-CoV-2 Ag RT2951 / RT 2952 97,3 90,0 - 99,8 100 96,6 - 100  
Azure Biotech,Inc Houston,Texas US NanoRepro AG Lotus NL B.V. The Hague NL Dia Sure COVID-19 Antigen Rapid Test Device   94,3 84,6 - 98,1 99,1 98,4 - 99,5 https://www.nanorepro.com/media/nanorepro-covid-19-antigen-ab-packungsbeilage.pdf
Beijing Beier Bioengineering Co., Ltd. Beijing CN High Lux International Trading GmbH MedNet EC-REP GmbH Münster DE COVID-19 Antigen Rapid Test Kit   96,5 93,7 - 99,3 99,7 99,0 - 100 http://www.beierbio.com/en/uploadfile/2020-10-23/4976409d-2b1c-4f47-8495-07d8e83b5a40.pdf
Beijing Hotgen Biotech Co., Ltd Beijing CN fameditec GmbH MedNet GmbH Münster DE CORA CHECK-19 4,27E+12 96,62   99,76   https://www.fameditec.de/cora-check-19-gebrauchsanweisung
Beijing Hotgen Biotech Co.,Ltd Peking CN Dr. Grob Healthcare MedNet GmbH Münster DE Coronavirus 2019-nCoV Antigen Test ANTIGEN97 97,1 93,80 - 98,93 99,76 98,65 - 99,99 http://www.dr-grob.com/antigen97
Beijing Lepu Medical Technology Co., Ltd Beijing CN Frohvogel Medizinprodukte UG Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) N/A 92 83,63 - 96,28 99,26 95,92 - 99,87 http://www.frohvogel.de/
Beijing Lepu Medical Technology Co., Ltd Beijing CN Deutsche HansaGT GmbH Lepu Medical (Europe) Cooperatief U.A Heerenveen NL Lepu SARS-CoV-2 Antigen Rapid Test Kit   92 83,63 - 96,28 99,26 95,92 - 99,87 https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/anleitung%2520Lepu.pdf
Beijing Lepu Medical Technology Co., Ltd Beijing CN Icon Medlab GmbH Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal GoldImmunochromatography)   92 83,63 - 96,28 99,26 95,92 - 99,87 https://www.iconmedlab.com/service
Beijing Lepu Medical Technology Co., Ltd Beijing CN Temiz AVZ GmbH Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)   92 83,63 - 96,28 99,26 95,92 - 99,87 https://www.antiviruszentrum.de/downloads/gebrauchsanweisung
Biohit Healthcare (Hefei) Co., Ltd. Hefei CN ScheBo Biotech AG ScheBo Biotech AG Gießen DE SARS-CoV-2 Antigen Rapid Test Kit 34 96,77 88,83 - 99,61 98,94 96,21 - 99,87 https://www.schebo.de/produkte/artikel-34-testanleitung/
Bionote, Inc. Hwaseong-si, Gyeonggi-do KR Concile GmbH MT Promedt Consulting GmbH St. Ingbert DE NowCheck COVID-19 Ag Test DE/CA70/40838/156134 89,2 81,7 - 93,9 97,6 95,1 - 98,8 https://bit.ly/3191UVD
Biosynex Swiss SA Freiburg CH Aidian Germany GmbH     FR BIOSYNEX COVID-19 Ag BSS SW40006 96 93,6 - 98,4 100 100 - 100 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Biosynex/IFU_SW40006_DE_V03202008R03.pdf
Boditech Med Inc. Chuncheon-si, Gang-won-do KR gurumB GmbH Obelis s.a Brussels BE ichroma™ COVI-19 Ag   90,4 83,2 - 94,7 97,6 91,5 - 99,3 https://www.gurumb.eu/ichroma-ii-covid-19-ag-de-gebrauchsanweisung
BTNX INC. Ontario L3R 4G7 CA NanoRepro AG MDSS GmbH Hannover DE Rapid Response COVID-19 Antigen Rapid Test Device COV-19C25 94,55 83,93 - 98,58 100 97,1 - 100 https://www.nanorepro.com/media/nanorepro-covid-19-antigen-packungsbeilage.pdf
CerTest Biotec S.L. Zaragoza ES bestbion dx GmbH     DE SARS-CoV-2 +  Flu A + B + RSV Quad Kassettenschnelltest inkl. Tupfer + pos. Kontrolle 03B11044 92,9 76,5 – 99,1 99,6 97,6 – 100,0 https://www.certest.es/wp-content/uploads/2020/09/QUAD_IU-SV86-v.01.pdf
CerTest Biotec S.L. Zaragoza ES bestbion dx GmbH     DE SARS-CoV-2 Kassettenschnelltest inkl. pos. Kontrolle 03B11041 92,9 76,5 – 99,1 99,6 97,6 – 100,0 https://www.certest.es/wp-content/uploads/2020/09/Web_SARS-CoV-2_SINGLE_IU-SC8-v.02.1.pdf
Devidia GmbH Weimar DE         DEDIATEST 2019-nCoV Antigen Rapid Test 2.13.1.555 96,5 92,6 - 98,7 99,5 97,2 - 99,9 https://www.testyounow.com/instructions
Edinburgh Genetics Limited Penicuik GB         Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit   91,2 90 - 92,4 98,6 97,8 - 99,4 https://www.eggenetics.com/wp-content/uploads/2020/10/Edinburgh-Genetics-ActivXpress-COVID-19-Antigen-Complete-Testing-Kit-German-v1.6.pdf
Fujirebio Inc. Shinjuku-ku,Tokyo JP Fujirebio Germany GmbH Fujirebio Europe N.V. Gent BE Lumipulse G SARS-CoV-2 Ag 260340 91,7 74,2 - 97,7 97,3 94,8 - 98,6 http://www.e-labeling.eu/FRI
GenBody Inc. Cheonan-si KR Meridian Bioscience Europe SRL MT Promedt Consulting GmbH Sankt ingbert DE GenBody COVID-19 Ag Cat. No.: COVAG025 90 73,47 - 97,89 98 92,96 - 99,76  
GenBody Inc. Chungcheongnam-do KR Preventor µTBC GmbH Preventor µTBC GmbH Pfungstadt DE GenBody Influenza/COVID-19 Multi Ag Schnelltest PRVCVIFG010-25 90 73,47 - 97,89 98 92,96 - 99,76 http://www.genbody.co.kr
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR IVC Pragen GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody-COVID-19 Ag COVAG025 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ivc-pragen.com\ivd
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR IVC Pragen GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody Influenza/COVID-19 Ag Multi CVIFG010 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ivc-pragen.com\ivd
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR ASCANUS Pharma GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody-COVID-19 Ag COVAG025 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ascanus.de/4_1_de.html
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR ASCANUS Pharma GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody Influenza/COVID-19 Ag Multi CVIFG010 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ascanus.de/4_1_de.html
Green Cross Medical Science Corp. Geumwang-eup, Eumseong-gun KR N/A MT Promedt Consulting GmbH St. Ingbert DE GENEDIA W COVID-19 Ag 643G 87,25 79,2 - 93,0 100 97,2 - 100 https://drive.google.com/file/d/1eZZEHoLs8S9-UutvAJ3LmWI1o_dk8eFl/view?usp=sharing
Guangdong Wesail Biotech Co., Ltd. Dongguan, Guangdong CN Bio-Gram Diagnostics GmbH Lotus NL B.V Gravenhagen NL Covid-19 AG Test Kit BE0040 82,5 68,05 - 91,25 98 96,36 - 98,91 https://bio-gram.de/wp-content/uploads/2020/10/Packungsbeilage-COVID-19-Ag-Test-Kit.pdf
Günter Keul GmbH Steinfurt DE         Keul-o-test® COVID-19 Antigen-Schnelltestkassette KGST230 90,4 79,0 - 96,8 99,5 97,2 - >99,9 https://keul.de/wp-content/uploads/2020/10/KGST231_COVID19_Antigen_Anleitung_Ger_1020.pdf
Günter Keul GmbH Steinfurt DE         Keul-o-test® COVID-19 und Influenza A+B Antigen Combotest KGST230 90,4 79,0 - 96,8 99,5 97,2 - 99,9 https://keul.de/wp-content/uploads/2020/10/KGST230_COVID19_Flu_Antigen-Combo_Anleitung_Ger_0920.pdf
Hangzhou AllTest Biotech Co, Ltd. Hangzhou CN TREKSTOR GmbH Lotus NL B.V. The Hague NL blnk COVID-19 and Influenza A+B Antigen Combo Rapid Test 30801 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.blnk-healthcare.com/ifu/GA_30801_Antigentest_Kombi_EN-IT-DE-201015.pdf
Hangzhou AllTest Biotech Co, Ltd. Hangzhou CN TREKSTOR GmbH Lotus NL B.V. The Hague NL blnk COVID-19 Antigen Rapid Test 30800 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.blnk-healthcare.com/ifu/GA_30800_Antigentest_EN-IT-DE-201015.pdf
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN Axon Lab AG Lotus NL B.V. The Hague NL COVID-19 Antigen Rapid Test   90,4 79,0 - 96,8 99,5 97,2 - 99,9 www.axonlab.de
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN PHARMADOC GmbH Lotus NL B.V. Den Haag NL COVID-19 und Influenza A+B Antigen Combo Schnelltest 146288202 90,4 79,0 - 96,8 99,5 97,2 - 99,9  
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN Axon Lab AG Lotus NL B.V. The Hague NL COVID-19 Antigen + Flu A/B Rapid Combo Test ICIC-525 90,4 79,0 - 96,8 99,5 97,2 - 99,9 www.axonlab.de
Hangzhou AllTest Biotech Co. Ltd. Hangzhou CN Preventis GmbH Lotus B.V. Verd, The Hague NL Covid-19  Antigen Rapid Test ICOV-502 90,4 79,0 - 96,8 99,5 97,2  - 99,9  
Hangzhou AllTest Biotech Co. Ltd. Hangzhou CN Preventis GmbH Lotus B.V. Verd, The Hague NL Covid-19  and Influenza A+B Antigen Rapid Test ICOV-525 90,4 79,0 - 96,8 99,5 97,2 - 99,9  
Hangzhou Clongene Biotech Co., Ltd. Hangzhou CN   Shanghai International Holding Corp.GmbH (Europe) Hamburg DE COVID-19 Antigen Rapid Test   98,5 91,8 - 99,7 100 98,2 - 100 http://en.clongene.com/uploads/20201026/84b3080010c296f2c6259666c2b80745.pdf
Hangzhou Laihe Biotech Co.,Ltd. Hangzhou , Zhejiang Province CN Lissner Qi GmbH SUNGO Europe B.V. Amsterdam NL Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) 303035 95,07 91,13 - 97,61 99,74 98,55 - 99,99 http://www.lissner-qi.de/aL628/w83720542d/Beipackzettel_DE.pdf
Hangzhou Lysun Biotechnology Co., Ltd Hangzhou CN Winlong GmbH Lotus NL B.V The Hague NL COVID-19 antigen Rapid Test Device (Colloidal Gold)   91,67 84,67 - 98,67 100 99,8 - 100 https://winlong.eu/wp-content/uploads/2020/10/Intruction-of-use-Lysun-2020-10.22.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN fameditec GmbH Luxus Lebenswelt GmbH Willich DE CORA CHECK-19   90,32 75,51 - 92,77 99,99 97,73 - 100 http://www.fameditec.de/cora-check-19-gebrauchsanweisung-25
Hangzhou Realy Tech Co., Ltd Hangzhou CN PHARMADOC GmbH Luxus Lebenswelt GmbH Willich DE Realy SARS-CoV-2 Antigen Schnelltest RT-K511416D 96,17 92,51 - 98,17 99,99 98,98  - 100 http://imaco.info/download/realy_codiv_beipack.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN TREKSTOR GmbH Luxus Lebenswelt GmbH Willich DE blnk Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) 30802 96,17 92,51 - 98,17 99,9 98,48 - 100 https://www.blnk-healthcare.com/ifu/GA_30802_Antigentest_EN-IT-DE.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN Dropshippers Germany, Ingo Grebe Luxus Lebenswelt GmbH Willich DE Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) K511416D 90,32 75,51 - 92,77 99,9 97,73 - 100 https://dropshippers-germany.de/wp-content/REALY_TECH_-_SARS-Cov-2_Antigen_Rapid_Test_-_Gebrauchsanweisung_-_v1607_-_Dropshippers_Germany.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN Winlong GmbH Luxus Lebenswelt GmbH Willich DE Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) K511416D 90,32 75,51 - 92,77 99,9 97,73 - 100 https://winlong.eu/wp-content/uploads/2020/10/Gebrauchsanweisung-Realy-Tech-Novel-Coronavirus-SARS-Cov-2-Antigen-Rapid-Test-Cassette-swab-25-test-ver-1.8-Winlong_DE.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN Deutsche HansaGT GmbH Luxus Lebenswelt GmbH Willich DE Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test   90,32 75,51 -  92,77 99,9 97,73 - 100 https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/Gebrauchsanweisung_Novel%2520Coronavirus%2520%2528SARS-Cov-2%2529%2520Antigen%2520Rapid%2520Test%2520Cassette%2520%2528swab%2529%252025%2520test%2520ver%25201.603.pdf
Healgen Scientific Limited Liability Company Houston US Siemens Healthcare GmbH Shanghai International Holding Corp. GmbH (Europe) Hamburg DE Clinitest Rapid COVID-19 Antigentest - Coronavirus Ag Rapid Test Cassette (Swab) 11555845 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://www.siemens-healthineers.com/de/point-of-care-testing/covid-19-testing/covid-19-tests/clinitest-covid-19-antigen-test
Healgen Scientific Limited Liability Company Houston US TriPart Logistic GmbH Shanghai International Holding Corp. GmbH (Europe) Hamburg DE Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://tripart-logistic.eu/transfer/Manual_v1.pdf
Healgen Scientific Limites Liability Company Huston US A. Menarini Diagnostics     DE Coronavirus Ag Rapid Test Cassette (Swab) GCOV-502-a (Menarinicode 51967) 96,3 87,25 - 99,55 99,06 96,63 - 99,89  
JOYSBIO (Tianjin) Biotechnology CO., LTD. Tianjin CN   Lotus NL B.V. The Hague NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) / Test Kit für neuartiges Coronavirus-Antigen (kolloidale Gold-Methode) COV-AG-20 / G10313 88,89 75,9 - 96,3 99,05 94,8 - 100,0 https://en.joysbio.com/wp-content/uploads/2020/10/JOYSBIO-SARS-COV-2-Antigen-Rapid-Test-Kit-IFU-German.pdf
LumiraDx UK Ltd. Alloa, Stirling UK LumiraDx GmbH LumiraDx AB Solna SE LumiraDx SARS-CoV-2 Ag Test L003000101048 97,5 87,1 - 99,6 97,7 94,7 - 99,0 https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-strip-product-insert-german.pdf
MEDsan GmbH Hamburg DE         MEDsan® SARS-CoV-2 Antigen Rapid Test T00023 (Single box) / T00019 (25er Packung) 92,5 86,4 - 96,0 99,8 98,9 - 100 https://www.medsan.eu/en/medsan-sars-cov-2-antigen-rapid-test-eu-version/
MEDsan GmbH Hamburg DE         MEDsan® Multiplex (SC2 & Flu A/B) Rapid Test T00032 (Single box) / T00033 (25er Packung) 92,5 86,4 - 96,0 99,8 98,9 - 100 https://www.medsan.eu/en/medsan-multiplex-sc2-flu-a-b-rapid-test-eu-version/
MEXACARE GmbH Heidelberg DE MEXACARE GmbH       COVID-19 Antigen (Nasen- Rachenabstrich) 3011030 93,5 82,4 - 97,1 99,5 94,2 - 99,7 https://www.mexacare.com/index.php?id=725
MEXACARE GmbH Heidelberg DE MEXACARE GmbH       COVID-19 & Influenza A+B Antigen Combo Schnelltest 30110333 93,75 86,14 - 97,3 98,3 91,1 - 99,9 https://www.mexacare.com/index.php?id=725
möLab GmbH Langenfeld DE         mö-screen Corona Antigen Test 230005 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://www.moelab.de/covid-19.html
nal von minden GmbH Moers DE         NADAL COVID-19 Ag Test 243103-N20 97,6 93,1 - 99,2 99,9 97,7 - 100 https://www.nal-vonminden.com/pdf/243103N-20_MPI%20A1_A2_COVID-19%20AgTest_20201012.pdf
nal von minden GmbH Moers DE         NADAL COVID-19 Ag+Influenza A/B Test 243203-N20 97,6 93,1 - 99,2 99,9 97,7 - 100 http://www.nal-vonminden.com/pdf/243203N-20_MPI%20A1_A2_COVID-19%20Ag%20Inf%20A%20B%20Test_20201012.pdf
nal von Minden GmbH Moers DE Axon Lab AG       NADAL® COVID-19 Ag Test 243103N-20 97,6 93,1 - 99,2 99,9 97,7 - 100 https://www.nadal-test.com/de
NanoEntek Inc Guro-gu,Seoul KR MS Med-Tech Supplies GmbH MT Promedt Consulting GmbH St. Ingbert DE FREND COVID-19 Ag FRCOG020 94,12 78,94 - 98,97 100 93,93 - 100 https://med-supplies.de/FREND_COVID-19_Ag_PI_DE.pdf
PCL, Inc. Geumcheon-gu, Seoul KR Datametrex AI Limited     DE PCL COVID19 Ag Rapid FIA   88,71 78,1 - 95,34 98,61 92,50 - 99,96  
Precision Biosensor Yuseong-gu, Daejeon KR Axon Lab AG MDI Europa GmbH Langenhagen DE Exdia COVID-19 Ag PR-FC13 93,88 83,5 - 97,9 98 89,5 - 99,6 https://drive.google.com/file/d/1He3GRrq01zySFkpmysTWn_Q3lob9AiRX/view?usp=drivesdk
Quidel Corporation San Diego, CA US Quidel Germany GmbH MDSS GmbH Hannover DE Sofia SARS Antigen FIA 20378 96,7 83,3 - 99,4 100 97,9 - 100 https://www.quidel.com/sites/default/files/product/documents/EF1451901DE00_08_20_Sofia_SARS_Antigen_XUS_Pkg_Insert.pdf
R-Biopharm AG Darmstadt DE         RIDA®QUICK SARS-CoV-2 Antigen N6803 95 84 - 99 100 66 - 100 https://clinical.r-biopharm.com/wp-content/uploads/sites/3/2020/10/n6803_ridaquick-sars-cov-2_antigen_2020-10-15_de.pdf
Salofa Oy Salu FI Promeditech GmbH       SIENNA COVID-19 Antigen Rapid Test Cassette 102241 95 83,1  - 99,4 99,2 97,6 - 99,8 https://shop.promeditech.de/documents/Sienna_Ag_102241_GBA_D-19102020.pdf
ScheBo Biotech AG Gießen DE ScheBo Biotech AG       ScheBo SARS-CoV-2 Quick ANTIGEN 34 96,77 88,83 - 99,61 98,94 96,21 - 99,87 https://www.schebo.de/wp-content/uploads/2020/10/ScheBo-SARS-CoV-2_QUICK_ANTIGEN_Gebrauchsanweisung_DE_GB.pdf
SD Biosensor Heungdeok-gu, Cheongju-si, Chungcheongbuk-do KR bestbion dx GmbH MT Promedt Consulting GmbH St. Ingbert DE Standard F COVID-19 Ag FIA Reagenzienkit 31B10008 94 80,32 - 99,28 97 83,3 - 99,92 https://bestbion.com/wp-content/uploads/2020/09/bestbiondx_GA_COVID19_FIA_20200916.pdf
SD Biosensor Heungdeok-gu, Cheongju-si, Chungcheongbuk-do KR bestbion dx GmbH MT Promedt Consulting GmbH St. Ingbert DE Standard Q Covid-19 Ag Reagenzienkit 31B20002 96,52 91,33 – 99,04 99,68 98,22 - 99,99 https://bestbion.com/sars-cov-2_covid-19/
SD Biosensor Inc. Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 KR Roche Diagnostics GmbH MT Promedt Consulting GmbH St. Ingbert DE SARS-CoV-2 Rapid Antigen Test 9327592190 96,52 91,33 - 99,04 99,68 98,22 - 99,99 https://www.roche.de/res/content/11722/packungsbeilage_sars-cov-2_rapid_antigen_test.pdf
Servoprax GmbH Wesel DE         Cleartest Corona-Antigen C3 4800-10/-20/-50/-100 96,5 92,6  - 98,7 99,5 97,2 - 99,9 https://data.servoprax.de/ftp/1-C3_4800-5ff-222-2-0002-2010.pdf
Shenzhen Microprofit Biotech Co., Ltd Shenzhen CN SVAN International Import & Export Co. Ltd. CMC Medical Devices & Drugs SL Malaga ES Fluorocare SARS-CoV-2 Spike Protein Test kit - Colloidal Gold AG01CGS 88,24 76,13 - 95,56 100 98,78 - 100 https://3ps-medical-care.de/
Shenzhen Microprofit Biotech Co., Ltd Shenzhen CN SVAN International Import & Export Co. Ltd. CMC Medical Devices & Drugs SL Malaga ES Fluorocare SARS-CoV-2 Spike Protein Test kit - Immunofluorescence type AG01IFS 92,16 81,12 - 97,82 100 98,78 - 100  
Sugentech, INC. Cheongju KR DiaSys Deutschland Vertriebs-GmbH MT Promedt Consulting GmbH St. Ingbert DE SGTi-flex COVID-19 Ag CAGT025E1 91,57 83,60 - 95,85 99 94,55 - 99,82 https://www.diasys-deutschland.de/produkte/schnelldiagnostika/
TaiDoc Technology Corporation New Taipei City TW   EC-REP MedNet GmbH Muenster DE VTRUST TD-4531 'COVID-19 Antigen Rapid Test'   85,7 65,4 - 95,0 98,6 92,4 - 100 https://www.dropbox.com/sh/yeycbehlb4tnily/AAC6Oq8o0_KY-mSXnX1dSTTga?dl=0
Unioninvest Ltd. Istanbul TR Science&Care Vertriebs GmbH Science&Care Vertriebs GmbH Laudenbach DE UNIBIOSCIENCE SARS-COV-19-2 AG SCHNELLTEST   97,44 95,47 - 98,72 99,3 98,68 - 99,68 http://bit.ly/Unibioscience_DE_IFU
VivaChek Biotech (Hangzhou) Co., Ltd. Hangzhou CN MSP bodmann GmbH Lotus NL B.V. The Hague NL VivaDiagTM SARS-CoV-2 Ag Schnelltest 59 90,9 81,55 - 95,77 100 99,12 - 100 https://mspbodmann.sharepoint.com/:b:/s/MSPDesign/ETfTSkULWZBBh-qqtXE6N-kBPy6PFxbsgQUJijoKjoKW2Q?e=Kdtmc9
VivaChek Biotech (Hangzhou) Co., Ltd. Hangzhou CN PHARMADOC GmbH Lotus NL B.V. Den Haag NL VivaDiagTM SARS-CoV-2 Ag Schnelltest VCD05-01-011 90,9 81,55 - 95,77 100 99,12 - 100 http://imaco.info/download/vivadiag_covid.pdf
Xiamen Biotime Biotechnology Co., Ltd. Fujan CN MEDICE Arzneimittel Pütter GmbH & Co. KG Logcon East GmbH Wien AT Medicovid-AG SARS-CoV-2 Antigen Schnelltest   96 88,75 - 100 100 98,34 - 100,0 https://medice.com/api/de-de/service/downloads/403000002001-gi-sars-cov-2-antigen-schnellt-medicovid.pdf
Xiamen Biotime Biotechnology Co Ltd. Xiamen CN   Logcon East GmbH Wien AT Biotime SARS-CoV-2 Antigen Rapid Qualitative Test   96 88,75 - 99,17 100 98,34 - 100,00 https://alpshealth.org/downloads/regulatory_materials/antigen/germany/SARS-CoV-2%20Antigen%20Test%20Gebrauchsanweisung_final-end.pdf
Zhejiang Orient Gene Biotech Co. Ltd Huzhou, Zhejiang CN A. Menarini Diagnostics Shanghai International Holding Corp GmbH(Europe) Hamburg DE Coronavirus Ag Rapid Test Cassette (Swab) GCOV-502-a (Menarinicode 51967) 96,3 87,25 - 99,55 99,06 96,63 - 99,89  
Zhejiang Orient Gene Biotech Co.,Ltd Huzhou CN Alphagen GmbH Shanghai International Holding Corp.GmbH (Europe) Hamburg DE Covid-19 Rapid Ag Test Cassette GCCOV-502a 96,72 88,65 - 99,6 99,22 97,21 - 99,91 https://www.alphascience.de/downloads/gebrauchsanweisung_covid-19_antigen_schnelltes.pdf

Sortiert nach "Sensitivität"

Hersteller Name Hersteller Stadt Hersteller Land Deutsche/r Vertreiber EU Bevollmächtigter Name EU Bevollmächtigter Stadt EU Bevollmächtigter Land Handelsname des Tests Artikelnummer Sensitivität % 95%iges Vertrauensintervall (Sensitivität) Spezifität % 95%iges Vertrauensintervall (Spezifität) Gebrauchsanweisung
Hangzhou Clongene Biotech Co., Ltd. Hangzhou CN   Shanghai International Holding Corp.GmbH (Europe) Hamburg DE COVID-19 Antigen Rapid Test   98,5 91,8 - 99,7 100 98,2 - 100 http://en.clongene.com/uploads/20201026/84b3080010c296f2c6259666c2b80745.pdf
nal von minden GmbH Moers DE         NADAL COVID-19 Ag Test 243103-N20 97,6 93,1 - 99,2 99,9 97,7 - 100 https://www.nal-vonminden.com/pdf/243103N-20_MPI%20A1_A2_COVID-19%20AgTest_20201012.pdf
nal von minden GmbH Moers DE         NADAL COVID-19 Ag+Influenza A/B Test 243203-N20 97,6 93,1 - 99,2 99,9 97,7 - 100 http://www.nal-vonminden.com/pdf/243203N-20_MPI%20A1_A2_COVID-19%20Ag%20Inf%20A%20B%20Test_20201012.pdf
nal von Minden GmbH Moers DE Axon Lab AG       NADAL® COVID-19 Ag Test 243103N-20 97,6 93,1 - 99,2 99,9 97,7 - 100 https://www.nadal-test.com/de
LumiraDx UK Ltd. Alloa, Stirling UK LumiraDx GmbH LumiraDx AB Solna SE LumiraDx SARS-CoV-2 Ag Test L003000101048 97,5 87,1 - 99,6 97,7 94,7 - 99,0 https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-strip-product-insert-german.pdf
Unioninvest Ltd. Istanbul TR Science&Care Vertriebs GmbH Science&Care Vertriebs GmbH Laudenbach DE UNIBIOSCIENCE SARS-COV-19-2 AG SCHNELLTEST   97,44 95,47 - 98,72 99,3 98,68 - 99,68 http://bit.ly/Unibioscience_DE_IFU
AMEDA Labordiagnostik GmbH Graz AT DIM LabService GmbH & Co. KG       AMP Rapid Test SARS-CoV-2 Ag RT2951 / RT 2952 97,3 90,0 - 99,8 100 96,6 - 100  
Beijing Hotgen Biotech Co.,Ltd Peking CN Dr. Grob Healthcare MedNet GmbH Münster DE Coronavirus 2019-nCoV Antigen Test ANTIGEN97 97,1 93,80 - 98,93 99,76 98,65 - 99,99 http://www.dr-grob.com/antigen97
Biohit Healthcare (Hefei) Co., Ltd. Hefei CN ScheBo Biotech AG ScheBo Biotech AG Gießen DE SARS-CoV-2 Antigen Rapid Test Kit 34 96,77 88,83 - 99,61 98,94 96,21 - 99,87 https://www.schebo.de/produkte/artikel-34-testanleitung/
ScheBo Biotech AG Gießen DE ScheBo Biotech AG       ScheBo SARS-CoV-2 Quick ANTIGEN 34 96,77 88,83 - 99,61 98,94 96,21 - 99,87 https://www.schebo.de/wp-content/uploads/2020/10/ScheBo-SARS-CoV-2_QUICK_ANTIGEN_Gebrauchsanweisung_DE_GB.pdf
Healgen Scientific Limited Liability Company Houston US Siemens Healthcare GmbH Shanghai International Holding Corp. GmbH (Europe) Hamburg DE Clinitest Rapid COVID-19 Antigentest - Coronavirus Ag Rapid Test Cassette (Swab) 11555845 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://www.siemens-healthineers.com/de/point-of-care-testing/covid-19-testing/covid-19-tests/clinitest-covid-19-antigen-test
Healgen Scientific Limited Liability Company Houston US TriPart Logistic GmbH Shanghai International Holding Corp. GmbH (Europe) Hamburg DE Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://tripart-logistic.eu/transfer/Manual_v1.pdf
möLab GmbH Langenfeld DE         mö-screen Corona Antigen Test 230005 96,72 88,65 - 99,60 99,22 97,21 - 99,91 https://www.moelab.de/covid-19.html
Zhejiang Orient Gene Biotech Co.,Ltd Huzhou CN Alphagen GmbH Shanghai International Holding Corp.GmbH (Europe) Hamburg DE Covid-19 Rapid Ag Test Cassette GCCOV-502a 96,72 88,65 - 99,6 99,22 97,21 - 99,91 https://www.alphascience.de/downloads/gebrauchsanweisung_covid-19_antigen_schnelltes.pdf
Quidel Corporation San Diego, CA US Quidel Germany GmbH MDSS GmbH Hannover DE Sofia SARS Antigen FIA 20378 96,7 83,3 - 99,4 100 97,9 - 100 https://www.quidel.com/sites/default/files/product/documents/EF1451901DE00_08_20_Sofia_SARS_Antigen_XUS_Pkg_Insert.pdf
Beijing Hotgen Biotech Co., Ltd Beijing CN fameditec GmbH MedNet GmbH Münster DE CORA CHECK-19 4,27E+12 96,62   99,76   https://www.fameditec.de/cora-check-19-gebrauchsanweisung
SD Biosensor Heungdeok-gu, Cheongju-si, Chungcheongbuk-do KR bestbion dx GmbH MT Promedt Consulting GmbH St. Ingbert DE Standard Q Covid-19 Ag Reagenzienkit 31B20002 96,52 91,33 – 99,04 99,68 98,22 - 99,99 https://bestbion.com/sars-cov-2_covid-19/
SD Biosensor Inc. Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 KR Roche Diagnostics GmbH MT Promedt Consulting GmbH St. Ingbert DE SARS-CoV-2 Rapid Antigen Test 9327592190 96,52 91,33 - 99,04 99,68 98,22 - 99,99 https://www.roche.de/res/content/11722/packungsbeilage_sars-cov-2_rapid_antigen_test.pdf
Beijing Beier Bioengineering Co., Ltd. Beijing CN High Lux International Trading GmbH MedNet EC-REP GmbH Münster DE COVID-19 Antigen Rapid Test Kit   96,5 93,7 - 99,3 99,7 99,0 - 100 http://www.beierbio.com/en/uploadfile/2020-10-23/4976409d-2b1c-4f47-8495-07d8e83b5a40.pdf
Devidia GmbH Weimar DE         DEDIATEST 2019-nCoV Antigen Rapid Test 2.13.1.555 96,5 92,6 - 98,7 99,5 97,2 - 99,9 https://www.testyounow.com/instructions
Servoprax GmbH Wesel DE         Cleartest Corona-Antigen C3 4800-10/-20/-50/-100 96,5 92,6  - 98,7 99,5 97,2 - 99,9 https://data.servoprax.de/ftp/1-C3_4800-5ff-222-2-0002-2010.pdf
Healgen Scientific Limites Liability Company Huston US A. Menarini Diagnostics     DE Coronavirus Ag Rapid Test Cassette (Swab) GCOV-502-a (Menarinicode 51967) 96,3 87,25 - 99,55 99,06 96,63 - 99,89  
Zhejiang Orient Gene Biotech Co. Ltd Huzhou, Zhejiang CN A. Menarini Diagnostics Shanghai International Holding Corp GmbH(Europe) Hamburg DE Coronavirus Ag Rapid Test Cassette (Swab) GCOV-502-a (Menarinicode 51967) 96,3 87,25 - 99,55 99,06 96,63 - 99,89  
Hangzhou Realy Tech Co., Ltd Hangzhou CN PHARMADOC GmbH Luxus Lebenswelt GmbH Willich DE Realy SARS-CoV-2 Antigen Schnelltest RT-K511416D 96,17 92,51 - 98,17 99,99 98,98  - 100 http://imaco.info/download/realy_codiv_beipack.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN TREKSTOR GmbH Luxus Lebenswelt GmbH Willich DE blnk Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) 30802 96,17 92,51 - 98,17 99,9 98,48 - 100 https://www.blnk-healthcare.com/ifu/GA_30802_Antigentest_EN-IT-DE.pdf
Biosynex Swiss SA Freiburg CH Aidian Germany GmbH     FR BIOSYNEX COVID-19 Ag BSS SW40006 96 93,6 - 98,4 100 100 - 100 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Biosynex/IFU_SW40006_DE_V03202008R03.pdf
Xiamen Biotime Biotechnology Co., Ltd. Fujan CN MEDICE Arzneimittel Pütter GmbH & Co. KG Logcon East GmbH Wien AT Medicovid-AG SARS-CoV-2 Antigen Schnelltest   96 88,75 - 100 100 98,34 - 100,0 https://medice.com/api/de-de/service/downloads/403000002001-gi-sars-cov-2-antigen-schnellt-medicovid.pdf
Xiamen Biotime Biotechnology Co Ltd. Xiamen CN   Logcon East GmbH Wien AT Biotime SARS-CoV-2 Antigen Rapid Qualitative Test   96 88,75 - 99,17 100 98,34 - 100,00 https://alpshealth.org/downloads/regulatory_materials/antigen/germany/SARS-CoV-2%20Antigen%20Test%20Gebrauchsanweisung_final-end.pdf
Hangzhou Laihe Biotech Co.,Ltd. Hangzhou , Zhejiang Province CN Lissner Qi GmbH SUNGO Europe B.V. Amsterdam NL Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) 303035 95,07 91,13 - 97,61 99,74 98,55 - 99,99 http://www.lissner-qi.de/aL628/w83720542d/Beipackzettel_DE.pdf
R-Biopharm AG Darmstadt DE         RIDA®QUICK SARS-CoV-2 Antigen N6803 95 84 - 99 100 66 - 100 https://clinical.r-biopharm.com/wp-content/uploads/sites/3/2020/10/n6803_ridaquick-sars-cov-2_antigen_2020-10-15_de.pdf
Salofa Oy Salu FI Promeditech GmbH       SIENNA COVID-19 Antigen Rapid Test Cassette 102241 95 83,1  - 99,4 99,2 97,6 - 99,8 https://shop.promeditech.de/documents/Sienna_Ag_102241_GBA_D-19102020.pdf
BTNX INC. Ontario L3R 4G7 CA NanoRepro AG MDSS GmbH Hannover DE Rapid Response COVID-19 Antigen Rapid Test Device COV-19C25 94,55 83,93 - 98,58 100 97,1 - 100 https://www.nanorepro.com/media/nanorepro-covid-19-antigen-packungsbeilage.pdf
Azure Biotech,Inc Houston,Texas US NanoRepro AG Lotus NL B.V. The Hague NL Dia Sure COVID-19 Antigen Rapid Test Device   94,3 84,6 - 98,1 99,1 98,4 - 99,5 https://www.nanorepro.com/media/nanorepro-covid-19-antigen-ab-packungsbeilage.pdf
NanoEntek Inc Guro-gu,Seoul KR MS Med-Tech Supplies GmbH MT Promedt Consulting GmbH St. Ingbert DE FREND COVID-19 Ag FRCOG020 94,12 78,94 - 98,97 100 93,93 - 100 https://med-supplies.de/FREND_COVID-19_Ag_PI_DE.pdf
SD Biosensor Heungdeok-gu, Cheongju-si, Chungcheongbuk-do KR bestbion dx GmbH MT Promedt Consulting GmbH St. Ingbert DE Standard F COVID-19 Ag FIA Reagenzienkit 31B10008 94 80,32 - 99,28 97 83,3 - 99,92 https://bestbion.com/wp-content/uploads/2020/09/bestbiondx_GA_COVID19_FIA_20200916.pdf
Precision Biosensor Yuseong-gu, Daejeon KR Axon Lab AG MDI Europa GmbH Langenhagen DE Exdia COVID-19 Ag PR-FC13 93,88 83,5 - 97,9 98 89,5 - 99,6 https://drive.google.com/file/d/1He3GRrq01zySFkpmysTWn_Q3lob9AiRX/view?usp=drivesdk
MEXACARE GmbH Heidelberg DE MEXACARE GmbH       COVID-19 & Influenza A+B Antigen Combo Schnelltest 30110333 93,75 86,14 - 97,3 98,3 91,1 - 99,9 https://www.mexacare.com/index.php?id=725
MEXACARE GmbH Heidelberg DE MEXACARE GmbH       COVID-19 Antigen (Nasen- Rachenabstrich) 3011030 93,5 82,4 - 97,1 99,5 94,2 - 99,7 https://www.mexacare.com/index.php?id=725
CerTest Biotec S.L. Zaragoza ES bestbion dx GmbH     DE SARS-CoV-2 +  Flu A + B + RSV Quad Kassettenschnelltest inkl. Tupfer + pos. Kontrolle 03B11044 92,9 76,5 – 99,1 99,6 97,6 – 100,0 https://www.certest.es/wp-content/uploads/2020/09/QUAD_IU-SV86-v.01.pdf
CerTest Biotec S.L. Zaragoza ES bestbion dx GmbH     DE SARS-CoV-2 Kassettenschnelltest inkl. pos. Kontrolle 03B11041 92,9 76,5 – 99,1 99,6 97,6 – 100,0 https://www.certest.es/wp-content/uploads/2020/09/Web_SARS-CoV-2_SINGLE_IU-SC8-v.02.1.pdf
MEDsan GmbH Hamburg DE         MEDsan® SARS-CoV-2 Antigen Rapid Test T00023 (Single box) / T00019 (25er Packung) 92,5 86,4 - 96,0 99,8 98,9 - 100 https://www.medsan.eu/en/medsan-sars-cov-2-antigen-rapid-test-eu-version/
MEDsan GmbH Hamburg DE         MEDsan® Multiplex (SC2 & Flu A/B) Rapid Test T00032 (Single box) / T00033 (25er Packung) 92,5 86,4 - 96,0 99,8 98,9 - 100 https://www.medsan.eu/en/medsan-multiplex-sc2-flu-a-b-rapid-test-eu-version/
Shenzhen Microprofit Biotech Co., Ltd Shenzhen CN SVAN International Import & Export Co. Ltd. CMC Medical Devices & Drugs SL Malaga ES Fluorocare SARS-CoV-2 Spike Protein Test kit - Immunofluorescence type AG01IFS 92,16 81,12 - 97,82 100 98,78 - 100  
Beijing Lepu Medical Technology Co., Ltd Beijing CN Frohvogel Medizinprodukte UG Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) N/A 92 83,63 - 96,28 99,26 95,92 - 99,87 http://www.frohvogel.de/
Beijing Lepu Medical Technology Co., Ltd Beijing CN Deutsche HansaGT GmbH Lepu Medical (Europe) Cooperatief U.A Heerenveen NL Lepu SARS-CoV-2 Antigen Rapid Test Kit   92 83,63 - 96,28 99,26 95,92 - 99,87 https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/anleitung%2520Lepu.pdf
Beijing Lepu Medical Technology Co., Ltd Beijing CN Icon Medlab GmbH Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal GoldImmunochromatography)   92 83,63 - 96,28 99,26 95,92 - 99,87 https://www.iconmedlab.com/service
Beijing Lepu Medical Technology Co., Ltd Beijing CN Temiz AVZ GmbH Lepu Medical (Europe) Cooperatief U.A. Heerenveen NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)   92 83,63 - 96,28 99,26 95,92 - 99,87 https://www.antiviruszentrum.de/downloads/gebrauchsanweisung
Fujirebio Inc. Shinjuku-ku,Tokyo JP Fujirebio Germany GmbH Fujirebio Europe N.V. Gent BE Lumipulse G SARS-CoV-2 Ag 260340 91,7 74,2 - 97,7 97,3 94,8 - 98,6 http://www.e-labeling.eu/FRI
Hangzhou Lysun Biotechnology Co., Ltd Hangzhou CN Winlong GmbH Lotus NL B.V The Hague NL COVID-19 antigen Rapid Test Device (Colloidal Gold)   91,67 84,67 - 98,67 100 99,8 - 100 https://winlong.eu/wp-content/uploads/2020/10/Intruction-of-use-Lysun-2020-10.22.pdf
Sugentech, INC. Cheongju KR DiaSys Deutschland Vertriebs-GmbH MT Promedt Consulting GmbH St. Ingbert DE SGTi-flex COVID-19 Ag CAGT025E1 91,57 83,60 - 95,85 99 94,55 - 99,82 https://www.diasys-deutschland.de/produkte/schnelldiagnostika/
Abbott Rapid Diagnostics Jena GmbH Jena DE Abbott Rapid Diagnostics Germany GmbH       Panbio™ COVID-19 Ag Rapid Test Device 41FK10 91,4 85,5 - 95,5 99,8 98,8 - 100 https://ensur.invmed.com/ensur/contentAction.aspx?key=ensur.547995.S2R4E4A3.20201014.11230.4318006
Edinburgh Genetics Limited Penicuik GB         Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit   91,2 90 - 92,4 98,6 97,8 - 99,4 https://www.eggenetics.com/wp-content/uploads/2020/10/Edinburgh-Genetics-ActivXpress-COVID-19-Antigen-Complete-Testing-Kit-German-v1.6.pdf
VivaChek Biotech (Hangzhou) Co., Ltd. Hangzhou CN MSP bodmann GmbH Lotus NL B.V. The Hague NL VivaDiagTM SARS-CoV-2 Ag Schnelltest 59 90,9 81,55 - 95,77 100 99,12 - 100 https://mspbodmann.sharepoint.com/:b:/s/MSPDesign/ETfTSkULWZBBh-qqtXE6N-kBPy6PFxbsgQUJijoKjoKW2Q?e=Kdtmc9
VivaChek Biotech (Hangzhou) Co., Ltd. Hangzhou CN PHARMADOC GmbH Lotus NL B.V. Den Haag NL VivaDiagTM SARS-CoV-2 Ag Schnelltest VCD05-01-011 90,9 81,55 - 95,77 100 99,12 - 100 http://imaco.info/download/vivadiag_covid.pdf
Acro Biotech Inc. Rancho Cucamonga US Aidian Germany GmbH MedNet GmbH Münster DE Acro COVID-19 and Influenza A+B Antigen Combo Rapid Test ICIC-ACO525 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300304_ICIC-525_ACRO_CE_EN_PI.pdf
Acro Biotech Inc. Rancho Cucamonga US Aidian Germany GmbH MedNet GmbH Münster DE Acro COVID-19 Antigen Rapid Test INCP-ACO502 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300204_ICOV-502_ACRO_CE_EN_PI.pdf
Boditech Med Inc. Chuncheon-si, Gang-won-do KR gurumB GmbH Obelis s.a Brussels BE ichroma™ COVI-19 Ag   90,4 83,2 - 94,7 97,6 91,5 - 99,3 https://www.gurumb.eu/ichroma-ii-covid-19-ag-de-gebrauchsanweisung
Günter Keul GmbH Steinfurt DE         Keul-o-test® COVID-19 Antigen-Schnelltestkassette KGST230 90,4 79,0 - 96,8 99,5 97,2 - >99,9 https://keul.de/wp-content/uploads/2020/10/KGST231_COVID19_Antigen_Anleitung_Ger_1020.pdf
Günter Keul GmbH Steinfurt DE         Keul-o-test® COVID-19 und Influenza A+B Antigen Combotest KGST230 90,4 79,0 - 96,8 99,5 97,2 - 99,9 https://keul.de/wp-content/uploads/2020/10/KGST230_COVID19_Flu_Antigen-Combo_Anleitung_Ger_0920.pdf
Hangzhou AllTest Biotech Co, Ltd. Hangzhou CN TREKSTOR GmbH Lotus NL B.V. The Hague NL blnk COVID-19 and Influenza A+B Antigen Combo Rapid Test 30801 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.blnk-healthcare.com/ifu/GA_30801_Antigentest_Kombi_EN-IT-DE-201015.pdf
Hangzhou AllTest Biotech Co, Ltd. Hangzhou CN TREKSTOR GmbH Lotus NL B.V. The Hague NL blnk COVID-19 Antigen Rapid Test 30800 90,4 79 - 96,8 99,5 97,2 - 99,9 https://www.blnk-healthcare.com/ifu/GA_30800_Antigentest_EN-IT-DE-201015.pdf
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN Axon Lab AG Lotus NL B.V. The Hague NL COVID-19 Antigen Rapid Test   90,4 79,0 - 96,8 99,5 97,2 - 99,9 www.axonlab.de
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN PHARMADOC GmbH Lotus NL B.V. Den Haag NL COVID-19 und Influenza A+B Antigen Combo Schnelltest 146288202 90,4 79,0 - 96,8 99,5 97,2 - 99,9  
Hangzhou AllTest Biotech Co., Ltd Hangzhou CN Axon Lab AG Lotus NL B.V. The Hague NL COVID-19 Antigen + Flu A/B Rapid Combo Test ICIC-525 90,4 79,0 - 96,8 99,5 97,2 - 99,9 www.axonlab.de
Hangzhou AllTest Biotech Co. Ltd. Hangzhou CN Preventis GmbH Lotus B.V. Verd, The Hague NL Covid-19  Antigen Rapid Test ICOV-502 90,4 79,0 - 96,8 99,5 97,2  - 99,9  
Hangzhou AllTest Biotech Co. Ltd. Hangzhou CN Preventis GmbH Lotus B.V. Verd, The Hague NL Covid-19  and Influenza A+B Antigen Rapid Test ICOV-525 90,4 79,0 - 96,8 99,5 97,2 - 99,9  
Hangzhou Realy Tech Co., Ltd Hangzhou CN fameditec GmbH Luxus Lebenswelt GmbH Willich DE CORA CHECK-19   90,32 75,51 - 92,77 99,99 97,73 - 100 http://www.fameditec.de/cora-check-19-gebrauchsanweisung-25
Hangzhou Realy Tech Co., Ltd Hangzhou CN Dropshippers Germany, Ingo Grebe Luxus Lebenswelt GmbH Willich DE Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) K511416D 90,32 75,51 - 92,77 99,9 97,73 - 100 https://dropshippers-germany.de/wp-content/REALY_TECH_-_SARS-Cov-2_Antigen_Rapid_Test_-_Gebrauchsanweisung_-_v1607_-_Dropshippers_Germany.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN Winlong GmbH Luxus Lebenswelt GmbH Willich DE Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) K511416D 90,32 75,51 - 92,77 99,9 97,73 - 100 https://winlong.eu/wp-content/uploads/2020/10/Gebrauchsanweisung-Realy-Tech-Novel-Coronavirus-SARS-Cov-2-Antigen-Rapid-Test-Cassette-swab-25-test-ver-1.8-Winlong_DE.pdf
Hangzhou Realy Tech Co., Ltd Hangzhou CN Deutsche HansaGT GmbH Luxus Lebenswelt GmbH Willich DE Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test   90,32 75,51 -  92,77 99,9 97,73 - 100 https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/Gebrauchsanweisung_Novel%2520Coronavirus%2520%2528SARS-Cov-2%2529%2520Antigen%2520Rapid%2520Test%2520Cassette%2520%2528swab%2529%252025%2520test%2520ver%25201.603.pdf
GenBody Inc. Cheonan-si KR Meridian Bioscience Europe SRL MT Promedt Consulting GmbH Sankt ingbert DE GenBody COVID-19 Ag Cat. No.: COVAG025 90 73,47 - 97,89 98 92,96 - 99,76  
GenBody Inc. Chungcheongnam-do KR Preventor µTBC GmbH Preventor µTBC GmbH Pfungstadt DE GenBody Influenza/COVID-19 Multi Ag Schnelltest PRVCVIFG010-25 90 73,47 - 97,89 98 92,96 - 99,76 http://www.genbody.co.kr
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR IVC Pragen GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody-COVID-19 Ag COVAG025 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ivc-pragen.com\ivd
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR IVC Pragen GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody Influenza/COVID-19 Ag Multi CVIFG010 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ivc-pragen.com\ivd
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR ASCANUS Pharma GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody-COVID-19 Ag COVAG025 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ascanus.de/4_1_de.html
GenBody Inc. Seobuk-gu, Cheonan-si, Chungcheongnam KR ASCANUS Pharma GmbH MT Promedt Consulting GmbH St.Ingbert DE GenBody Influenza/COVID-19 Ag Multi CVIFG010 90 73,47 - 97,89 98 92,96 - 99,76 http://www.ascanus.de/4_1_de.html
Bionote, Inc. Hwaseong-si, Gyeonggi-do KR Concile GmbH MT Promedt Consulting GmbH St. Ingbert DE NowCheck COVID-19 Ag Test DE/CA70/40838/156134 89,2 81,7 - 93,9 97,6 95,1 - 98,8 https://bit.ly/3191UVD
JOYSBIO (Tianjin) Biotechnology CO., LTD. Tianjin CN   Lotus NL B.V. The Hague NL SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) / Test Kit für neuartiges Coronavirus-Antigen (kolloidale Gold-Methode) COV-AG-20 / G10313 88,89 75,9 - 96,3 99,05 94,8 - 100,0 https://en.joysbio.com/wp-content/uploads/2020/10/JOYSBIO-SARS-COV-2-Antigen-Rapid-Test-Kit-IFU-German.pdf
PCL, Inc. Geumcheon-gu, Seoul KR Datametrex AI Limited     DE PCL COVID19 Ag Rapid FIA   88,71 78,1 - 95,34 98,61 92,50 - 99,96  
Shenzhen Microprofit Biotech Co., Ltd Shenzhen CN SVAN International Import & Export Co. Ltd. CMC Medical Devices & Drugs SL Malaga ES Fluorocare SARS-CoV-2 Spike Protein Test kit - Colloidal Gold AG01CGS 88,24 76,13 - 95,56 100 98,78 - 100 https://3ps-medical-care.de/
Green Cross Medical Science Corp. Geumwang-eup, Eumseong-gun KR N/A MT Promedt Consulting GmbH St. Ingbert DE GENEDIA W COVID-19 Ag 643G 87,25 79,2 - 93,0 100 97,2 - 100 https://drive.google.com/file/d/1eZZEHoLs8S9-UutvAJ3LmWI1o_dk8eFl/view?usp=sharing
TaiDoc Technology Corporation New Taipei City TW   EC-REP MedNet GmbH Muenster DE VTRUST TD-4531 'COVID-19 Antigen Rapid Test'   85,7 65,4 - 95,0 98,6 92,4 - 100 https://www.dropbox.com/sh/yeycbehlb4tnily/AAC6Oq8o0_KY-mSXnX1dSTTga?dl=0
Guangdong Wesail Biotech Co., Ltd. Dongguan, Guangdong CN Bio-Gram Diagnostics GmbH Lotus NL B.V Gravenhagen NL Covid-19 AG Test Kit BE0040 82,5 68,05 - 91,25 98 96,36 - 98,91 https://bio-gram.de/wp-content/uploads/2020/10/Packungsbeilage-COVID-19-Ag-Test-Kit.pdf

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