Testkits

Aktenzeichen des BfArM Name des Tests Hersteller Bei freetogo verfügbar? Probennahme Sensitivität % Spezifität % Gebrauchsanweisung
5640-S-216/21 Panbio™ COVID-19 Antigen Self-Test Abbott Rapid Diagnostics Jena GmbH Ja nasal 98,10 99,80
5640-S-036/21 Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit Acura Kliniken Baden-Baden GmbH Ja Speichel 98,10 99,33 https://acura-kliniken.com/wp-content/uploads/2021/04/Gebrauchsanweisung.pdf
5640-S-022/21 AESKU.RAPID SARS-CoV-2 Aesku.Diagnostics GmbH & Co. KG Ja nasal 96,00 98,00 https://www.aesku.com/images/images/service/pdf/AESKU.RAPID_quickguide_laie_004_de.pdf
5640-S-116/21 Clungene COVID-19 Antigen Schnelltest (Spucktest) amec GmbH Ja Speichel 91,30 99,60 https://www.amec-gmbh.de/wp-content/uploads/amec_Gebrauchsanweisung_Laie_17032021.pdf
5640-S-062/21 AMP Rapid Test SARS-CoV-2 Ag AMEDA Labordiagnostik GmbH Ja nasal 97,30 100,00 https://2e5ed920-9a4a-4c1f-b46e-954bdc354cc4.filesusr.com/ugd/3cc657_8e8255a9bf56497a8490327602d78955.pdf
5640-S-061/21 AMP Rapid Test SARS-CoV-2 Ag Sputum AMEDA Labordiagnostik GmbH Ja Sputum 92,20 100,00 https://2e5ed920-9a4a-4c1f-b46e-954bdc354cc4.filesusr.com/ugd/3cc657_b763a3b7ed0f45bba0aeba92bd9727af.pdf
5640-S-310/21 COVID-19 Antigen Schnelltest (kolloidales Gold)/Nasenabstrich Anbio (Xiamen) Biotechnology., Co Ltd Ja nasal 93,87 100,00 http://bb1tdy.r12.35.com/forum/productfiledownload?token=506bOl6%2BxwjpNv%2FDXtAOGeJ9%2FRUISVAp9g6UFlSLpq9HoytYlLx0a3Q
5640-S-058/21 COVID-19 Antigen Schnelltest (KolloidalesGold) Anbio (Xiamen) Biotechnology Co., Ltd. Nein Speichel 98,94 100,00
5640-S-086/21 COVID-19 (SARS-CoV-2) Antigentest (kolloidales Gold) Anhui Deepblue Medical Technology Co., Ltd. Ja nasal 96,40 99,80 https://waimao-us-west.oss-us-west-1.aliyuncs.com/customerFiles/dbluemedical/2021/04/15/b14c185096cd7580a3e6af3d27166f7726b6e8d7.pdf
5640-S-087/21 COVID-19 (SARS-CoV-2) Antigentestkit (kolloidales Gold) – Speichel Anhui Deepblue Medical Technology Co. Ltd. Ja Speichel 97,10 99,80 https://waimao-us-west.oss-us-west-1.aliyuncs.com/customerFiles/dbluemedical/2021/04/15/5cdec64f353d5b4b908e6381b95832a340dceb94.pdf
5640-S-100/21 COVID-19 N Antigen Schnelltest SARS-CoV-2 (vorderer Nasenabstrich) Aripa Biotec GmbH Ja nasal 98,40 98,80 https://aripa-biotec.com/wp-content/uploads/2021/04/Packungsbeilage-AntigenSchnelltest_PDF_LAIEN_ARIPA_20210326_FINAL.pdf
5640-S-122/21 NOVA Test® SARS-CoV-2 Antigen Schnelltestkit (Kolloidale Gold Immunchromatographie) Atlas Link Technology Co., Ltd Nein nasal 92,00 100,00 http://www.unilatex.com.sg/AT-LNovatestAg(1).pdf
5640-S-316/21 Dia Sure COVID-19 Antigen Schnelltest Azure Biotech Inc. Nein nasal 91,40 100,00 http://www.azure.bio/wp-content/uploads/2021/05/316-21-IFU_20Tests.pdf
5640-S-080/21 Coronavirus (2019-nCoV)-Antigentest – Speichel Beijing Hotgen Biotech Co.,Ltd Ja Speichel 96,30 99,13 https://maiimg.com/pdf/?e=agA2x6j6iIAhcm
5640-S-057/21 Coronavirus (2019-nCoV)-Antigentest Beijing Hotgen Biotech Co.,Ltd Ja nasal 95,37 99,13 https://dr-grob.com/Gebrauchsanweisung_ANTIGEN_Laientest.pdf
5640-S-094/21 WANTAI SARS-CoV-2 Ag Schnelltest (Kolloidales Gold) Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Ja Speichel / nasal 95,40 99,60 http://www.ystwt.cn/wp-content/uploads/2021/04/Wantai-SARS-CoV-2-Ag-Rapid-Test-self-test-IFU1Test-BfArM.pdf
5640-S-118/21 COVID-19 Ag Test Kit Bio-Gram Diagnostics GmbH Nein nasal 82,40 99,70
5640-S-041/21 BIOSYNEX COVID-19 Ag BSS Biosynex Suisse SA Ja nasal 97,20 100,00
5640-S-214/21 Testsealabs® COVID-19 (SARS-CoV-2) Antigen Schnelltest Brawa GmbH Ja nasal 94,40 98,40 https://shop.testsealabs.de/import/Gebrauchsanweisung.pdf
5640-S-078/21 COVID-19 Antigen Rapid Test CHIL TIBBI MAL. SAN. VE TIC. AS. Nein nasal 98,55 99,57 https://mca-management.de/downloads/chil_swab_antigen_laie_280421.pdf
5640-S-017/21 Canea Covid-19 Antigen Speichel Selbsttest Core Technology  Co. Ltd. Nein Speichel 97,60 99,10
5640-S-069/21 Core tests® COVID-19 Ag Test Core Technology Co. Ltd. Nein nasal 98,10 99,20 https://drive.google.com/file/d/1DstyRBE5-q6kpTM6hePmgnTJuF5lqZDJ/view?usp=sharing
5640-S-233/21 SARS-CoV-2 Antigentest Kit (Kolloidales Gold) – Laientest / Selbsttest Deucin GmbH Nein nasal 91,15 99,02
5640-S-164/21 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) EJOY-GmbH Ja nasal 95,91 100,00
5640-S-399/21 COVID-19 Ag Antigen Selbsttest zur Eigenanwendung Eurobio Scientific Nein nasal 93,28 99,20
5640-S-154/21 CORA-CHECK-19 comfort fameditec GmbH Nein Speichel 96,30 99,13
5640-S-288/21 SARS-CoV-2 Antigentest Kit (Kolloidales Gold) Genrui Biotech Inc. Nein Speichel 90,18 99,01 http://www.genrui-bio.com/u_file/images/21_06_25/176990eb31.pdf
5640-S-219/21 SARS-COV-2 Antigentest Kit (Kolloidales Gold) Genrui Biotech Inc. Nein nasal 91,15 99,02 http://www.genrui-bio.com/u_file/images/21_05_25/6f2b636719.pdf
5640-S-411/21 GenSureTM COVID-19 Antigen-Schnelltest SPUCKEN GenSure Biotech Inc. Nein 96,73 100,00 https://www.xirion-solutions.de/downloads/GenSure_Packungsbeilage_Spucktest.pdf
5640-S-166/21 GenSureTM COVID-19 Antigen-Schnelltest NASAL GenSure Biotech Inc. Nein Speichel 96,86 100,00 https://www.xirion-solutions.de/downloads/GenSure_Packungsbeilage_Nasaltest.pdf
5640-S-185/21 einstufiger Test für SARS-COV-2-Antigen Getein Biotech Inc. Ja nasal 97,06 98,71 https://www.asiatrading-group.eu/wp-content/uploads/2021/06/2204_Manual_corrections_bfarm_GE_MC4_AP4_DrSt1.pdf
5640-S-230/21 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) Guangdong Longsee Biomedical Co., Ltd. Nein Speichel 87,58 99,09 https://en.longseemed.com/static/pdf/LS-C-T-008-new.pdf
5640-S-103/21 SARS-CoV-2 Antigen-Saliva / Sputum-Test Spucktest Guangzhou Wondfo Biotech Co., Ltd Ja Speichel / Sputum 97,60 99,09
5640-S-245/21 SARS-CoV-2 Antigentest Kit (Kolloidales Gold) – Laientest / Selbsttest Günter Keul GmbH Ja nasal 91,15 99,02
5640-S-178/21, 5640-S-179/21 Wondfo 2019-nCoV Antigen Test (Lateral-Flow-Methode) Selbsttest Haemato Pharm GmbH Ja nasal 97,83 99,08 https://www.schnelltest-antigen.de/wp-content/uploads/2021/03/21-04-12-IFU-Wondfo-Antigentest-nasal-Laientest.pdf
5640-S-168/21 COVID-19 Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd. Ja nasal 91,40 99,40
5640-S-244/21 SARS-CoV-2-Antigenschnelltest (Nasenabstrich) Hangzhou Immuno Biotech Co., Ltd. Nein nasal 93,64 100,00
5640-S-082/21 SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag) für Laien Hangzhou Immuno Biotech Ltd. Co. Nein Sputum 94,12 99,75 https://www.immuno-test.com/uploads/V1.0_SARS-CoV-2-Antigen-Schnelltest-fu%CC%88r-Laien_GebrauchsanleitungDE1.pdf
5640-S-009/21 LYHER® Covid-19 Antigen Schnelltest (Nasal) Hangzhou Laihe Biotech Ltd., Co. Ja nasal 95,00 99,60
5640-S-028/21 SARS-CoV-2 Antigen Rapid Test Kit Icon Medlab GmbH Ja nasal 95,06 99,62
5640-S-091/21 COVID-19-Antigen-Schnelltestkit (kolloidales Gold)  ) Jiang su Diagnostic Biotechnology Co., Ltd. Nein nasal 98,11 100,00
5640-S-286/21 SARS-CoV2 Antigen Test Kit (LFIA) Jiangsu Medomics Medical Technology Co., Ltd Nein nasal 95,54 99,04
5640-S-240/21 Covid-19 Antigen Rapid Test (Colloidal Gold) Joinstar Biomedical Technology Co., Ltd Ja nasal 96,10 99,20 https://www.alpstar.at/upload/medialibrary/4.6_JOINSTAR_LAIENSTEST__Colloidal_Gold____ALPSTAR_Gebrauchsanweisung.pdf
5640-S-151/21 COVID-19 Antigen Schnelltest (kolloidales Gold) Probenmaterial: vorderer Nasenabstrich JOINSTAR BIOMEDICAL TECHNOLOGY CO., LTD. Ja nasal 96,10 99,20
5640-S-243/21 COVID-19 Antigen Schnelltest (kolloidales Gold) Probe: Speichel (Spucktest) JOINSTAR BIOMEDICAL TECHNOLOGY CO., LTD. Nein Speichel 96,10 99,20
5640-S-291/21 SARS-CoV-2 Antigen-Schnelltest (Immunochromatographie) Labnovation Technologies, Inc. Ja nasal http://www.labnovation.com/products/1415.html
5640-S-225/21 LAMA SARS-Cov-2-Antigen- Saliva/Sputum-Test Spucktest zur Eigenanwendung Lama Licensing GmbH Nein Speichel / Sputum 97,60 99,09
5640-S-266/21 PocRoc®SARS-CoV-2 Antigen Schnelltest Set (Kolloidales Gold) Lumigenex (Suzhou) Co., Ltd. Nein nasal 93,33 99,43 http://www.lumigenex.com/SARS-CoV-2%20Antigen%20Rapid%20Test.html
5640-S-128/21 Medicovid-AG SARS-CoV-2 Antigen Schnelltest – Nase MEDICE Arzneimittel Pütter GmbH & Co. KG Ja nasal 96,19 99,20 https://medice.com/api/de-de/produkte/corona-tests/medicovid-ag-r-sars-cov-2-antigen-selbsttest/403000003202-gi-sars-cov2-antigen-selbsttest-nase-1-5-1.pdf
5640-S-167/21 MEDsan® SARS-CoV-2 Ag Duo Home MEDsan GmbH Nein nasal
5640-S-049/21 MEXACARE Corona Home-Test ‚Antigen‘ Mexacare GmbH Ja nasal 96,10 99,20 https://mexacare.com/wp-content/uploads/2020/09/MX_Covid-19AgOTCnoCE_IFU_DE_190521_1.7_A3.pdf
5640-S-147/21 COVID-19 Antigen-Schnelltest (Kolloidales Gold) MR Sanicom GmbH Ja Speichel 96,10 99,00 https://www.mr-sanicom.de/wp-content/uploads/2021/04/Gebrauchsanleitung-mrsanicom-antigen-schnelltest.pdf
5640-S-045/21 NADAL® COVID-19 Ag Test nal von minden GmbH Ja nasal 94,10 99,99 http://www.nal-vonminden.com/pdf/DE05de00150_pi_ZV_NADAL%C2%AE COVID-19 Ag Test (Ref. 243103N-20H)_homeuse_Rev03.02_D.pdf
5640-S-364/21 Novel Coronavirus (2019-nCoV) Antigen Testing Kit  (Colloidal Gold) Nanjing Norman Biological Technology Co., Ltd Nein Speichel / nasal 91,13 99,09
5640-S-343/21 COVID-19 Antigen Test Kit (Colloidal Gold) – Anterior nasal Nantong Diagnos Biotechnology Co.,Ltd. Nein nasal 97,73 99,44
5640-S-296/21 Covid-19-Antigen-Testkit New Gene (Hangzhou) Bioengineering Co., Ltd Nein nasal 97,10 99,20
5640-S-227/21 SARS-CoV-2 Antigen Rapid Test Novatech Tibbi Cihaz Ürünleri Sanayi ve Ticaret A.S Nein nasal 95,91 100,00
5640-S-146/21 Sensitivo COVID-19 Antigen Test OFM GmbH Ja nasal 98,86 100,00 https://www.ofm-medical.de/wp-content/uploads/2021/04/OFM_Medical_Sensitivo-COVID-19-Antigen-Test_Gebrauchsanweisung_Laien.pdf
5640-S-140/21 Deni COVID-19 Antigen Test OFM GmbH Ja nasal 96,80 100,00 https://www.ofm-medical.de/gebrauchsanweisungen/
5640-S-273/21 CAT COVID-19 Antigen Schnelltest (Nucle-ocapsid) Oncosem Nein nasal https://oncosem.com/273-21-short-ifu-ger/
5640-S-063/21 PCL COVID19 Ag Gold PCL Inc. Ja Speichel / Sputum / nasal 90,83 99,50 http://www.pclchip.com/eng/sub_n4/4_6.php?mode=view&number=904&page=1&b_name=eng_notice
5640-S-031/21 SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic assay) PerGrande BioTech Development Co., Ltd. Ja nasal 94,78 99,05
5640-S-020/21 (SARS-CoV-2) Antigen Rapid test COVIDENT COVID-19 Pierenkemper GmbH Ja Speichel 99,27 100,00
5640-S-015/21 HIGHTOP SARS-CoV-2 (COVID-19) Antigen Rapid Test Qingdao Hightop Biotech Co., Ltd. Ja nasal 98,08 99,80
5640-S-123/21 COVID-19 Antigen Rapid Test kit(Swab) (self-testing) Safecare Biotech (Hangzhou) Co., Ltd. Nein nasal 97,52 99,40
5640-S-474/21 Green Spring® SARS-CoV-2-Antigen-Schnelltest-Set Shenzhen Lvshiyuan Biotechnology Co.,Ltd Nein nasal 96,80 100,00 https://www.lsybt.com/En/ProDetail.aspx?c_id=76&id=978
5640-S-032/21 SARS-CoV-2 Antigen Schnelltest zur Eigen-anwendung (kolloidales Gold) Shenzhen Watmind Medical Co., Ltd. Ja Speichel 90,45 99,45 https://en.watmind.com/Private/Files/20210624/6376016273505205312004002.pdf
5640-S-177/21 COVID-19 Antigen Testkassette(Nasenabstrich) Shenzhen zhenrui Biotech Co.,Ltd Nein nasal 93,00 97,00
5640-S-055/21 COVID-19 Antigen Testkassette(Speichel) Shenzhen zhenrui Biotech Co.,Ltd Nein Speichel 85,60 97,30
5640-S-292/21 REDTEST  SARS-CoV-2 ANTIGEN RAPID TEST  (COVID-19 AG) Sigmed Sp. z o.o. Nein nasal 98,13 100,00
5640-S-056/21 SGTi-flex COVID-19 Ag Sugentech, Inc. Ja nasal 95,06 99,29
5640-S-079/21 ANBIO Corona Antigen Nasentupfer Teda Laukoetter Technologie GmbH Ja nasal 93,87 100,00
5640-S-339/21 SARS-CoV-2 Antigen Rapid Test Kit Triplex International Biosciences (China) Co., LTD. Nein nasal 99,00 100,00
5640-S-053/21 RapidFor SARS-CoV-2 Rapid Antigen Test Vitrosens Biyoteknoloji Ltd. Sti. Ja nasal 97,03 99,00
5640-S-156/21 SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) WQS Management Consultants GmbH Ja nasal 95,06 98,54 https://www.wqs.de/wp-content/uploads/2021/04/IFU_SARS_376x276_4.1_farbig.pdf
5640-S-199/21 COVID-19 (SARS-CoV-2) Antigen-Testkit Wuhan EasyDiagnosis Biomedicine Co., Ltd. Nein nasal 95,00 99,35 http://www.easydiagnosis.com.cn/staticPDF/GE-Ag-layperson-IFU.pdf
5640-S-206/21 SARS-CoV-2 ANTIGEN RAPID TEST (Saliva)  Speichel Schnelltest – Eigenanwendung XIAMEN WIZ BIOTECH Co., Ltd. Nein Speichel 95,35 100,00
5640-S-210/21 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) XIAMEN WIZ BIOTECH Co., Ltd. Nein nasal 95,91 100,00
5640-S-064/21 ‚AndLucky‘ SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasive) Zhejiang Anji Saianfu Biotech Co., Ltd. Nein nasal 97,50 99,10
5640-S-004/21 COVID-19 Antigen Rapid Test, Clungene Hangzhou Clongene Biotech Co., Ltd. Ja Nasal http://en.clongene.com/uploads/20210414/93ab830f321c04cdcbbc35600fd86a23.pdf
5640-S-076/21 Rapid SARS-CoV-2 Antigen Test Card MP Biomedicals Germany GmbH Ja Nasal https://media.mpbio.com/document/file/manual/dest/s/a/r/s/c/SARS-CoV-2_Antigen_Test_Card_07AG6020B-009-03-12-DE.pdf
AT001/20 CLINITEST Rapid COVID-19 Self-Test Healgen Scientific LLC Siemens Ja Nasal https://cdn0.scrvt.com/39b415fb07de4d9656c7b516d8e2d907/312a3a8c8a89f5b0/5e640bcc7f09/CLINITEST-Rapid-COVID-19-Antigen-Test-PI-Healgen-CE-Rev.-G_German.pdf
5640-S-025/21 SARS-CoV-2 Rapid Antigen Test       Roche SD BIOSENSOR, INC Ja Nasal https://assets.cwp.roche.com/f/94122/x/b01d9b8de3/sars-cov-2-ragt-nasal_1-0_qrg_ifu_09461752001-01_de_pst-special-permit.pdf
5640-S-007/21 CLRapid SARS-CoV-2 Antigen Test Card Xiamen Boson Biotech Co., Ltd Ja nasal
5640-S-096/21 NanoRepro Antigen Schnelltest (Viromed) NanoRepro Antigen Rapid Test (Viromed) Ja Nasal https://www.viromed.de/wp-content/uploads/2021/03/NanoRepro_SARS-CoV-2_PB_VIROMED_Rev00_202103_1er_ENDKUNDE.pdf
5640-S-171/21 ACON SARS-CoV-2-Antigenschnelltest (Selbsttest) Ja Nasal https://www.dialab.at/fileadmin/user_upload/document/Flyer_Catalogues/Flyer_ACON_SARS-CoV-2_Ag_Schnelltest_Deutsch_01.pdf
AT195/21 COVID-19 Antigen Schnelltest (Kolloidales Gold) Anbio (Xiamen) Biotechnology Co., Ltd. Ja Nasal https://www.lgc-hygiene.de/media/73/46/94/1617966579/New%20HYGISUN%20COVID-19%20Antigen%20Schnelltest%20(Kolloidales%20Gold)%20V7(300box).pdf
5640-S-104/21 NASOCHECKcomfort SARS-CoV-2 Antigen-Schnelltest Ja Nasal https://volksversand.de/import/pdf/lepu_nasocheckcomfort_10278100.pdf
5640- S-032/21 watmind SARS-CoV-2 Antigen Lolly-Schnelltest zur Eigenanwendung Ja Speichel https://cdn.shop-apotheke.com/pdf/D08106038-bp.pdf