medizinische
Atemschutzmasken
Aktenzeichen der Sonderzulassung des BfArM | Hersteller | Antragsteller | Testname | BfArM-AT-Nummer | LoD-Wert in TCID50/mL |
5640-S-004/21 | Healgen Scientific LLC | Siemens Healthcare Diagnostics Products GmbH | CLINITEST Rapid COVID-19 Self-Test | AT001/20 | 115 |
5640-S-007/21 | Xiamen Boson Biotech Co., Ltd | Technomed Service GmbH | Rapid SARS-CoV-2 Antigen Test Card | AT116/20 | 130 |
5640-S-009/21 | Hangzhou Laihe Biotech Ltd., Co. | Lissner Qi GmbH | LYHER® Covid-19 Antigen Schnelltest (Nasal) | AT011/20 | |
5640-S-025/21 | SD BIOSENSOR, INC. | MT Promedt Consulting GmbH | SARS-CoV-2 Rapid Antigen Test | AT307/21 | 936,1 |
5640-S-062/21 | AMEDA Labordiagnostik GmbH | AMEDA Labordiagnostik GmbH | AMP Rapid Test SARS-CoV-2 Ag | AT033/20 | 115 |
5640-S-057/21 | Beijing Hotgen Biotech Co., Ltd | Beijing Hotgen Biotech Co., Ltd | Coronavirus (2019-nCoV)-Antigentest | AT282/21 | 396,22 |
5640-S-022/21 | Aesku.Diagnostics GmbH & Co. KG | Aesku.Diagnostics GmbH & Co. KG | AESKU.RAPID SARS-CoV-2 | AT363/20 | 50 |
5640-S-096/21 | NanoRepro AG | NanoRepro AG | NanoRepro Antigen Schnelltest (Viromed)/NanoRepro Antigen Rapid Test (Viromed) | 30 | |
5640-S-076/21 | MP Biomedicals Germany GmbH | MP Biomedicals Germany GmbH | Rapid SARS-CoV-2 Antigen Test Card | 130 | |
5640-S-041/21 | Biosynex Suisse SA | Biosynex Suisse SA | BIOSYNEX COVID-19 Ag BSS | AT025/20 | 115 |
5640-S-168/21 | Hangzhou Clongene Biotech Co., Ltd. | Hangzhou Clongene Biotech Co., Ltd. | COVID-19 Antigen Rapid Test | AT373/21 | 570,4 |
5640-S-128/21 | MEDICE Arzneimittel Pütter GmbH & Co. KG | MEDICE Arzneimittel Pütter GmbH & Co. KG | Medicovid-AG SARS CoV-2 Antigen SELBSTTEST NASE | 130 | |
5640-S-116/21 | amec GmbH | amec GmbH | COVID-19 Antigen Schnelltest (Spucktest) | 860 | |
5640-S-147/21 | MR Sanicom GmbH | MR Sanicom GmbH | COVID-19 Antigen-Schnelltest (Kolloidales Gold) | 100 | |
5640-S-079/21 | Teda Laukoetter Technologie GmbH | Teda Laukoetter Technologie GmbH | ANBIO Corona Antigen Nasentupfer | 433,5 | |
5640-S-080/21 | Beijing Hotgen Biotech Co.,Ltd | Beijing Hotgen Biotech Co.,Ltd | Coronavirus (2019-nCoV)-Antigentest - Speichel | AT095/21 | 396,22 |
5640-S-178/21 | Haemato Pharm GmbH | Haemato Pharm GmbH | Wondfo 2019-nCoV Antigen Test (Lateral-Flow-Methode) Selbsttest | 110 | |
5640-S-146/21 | OFM GmbH | OFM GmbH | Sensitivo COVID-19 Antigen Test | 50 | |
5640-S-104/21 | Beijing Lepu Medical Technology Co., Ltd. | Beijing Lepu Medical Technology Co., Ltd. | NASOCHECKcomfort SARS-CoV-2 Antigen-Schnelltest | 200 | |
5640-S-100/21 | Aripa Biotec GmbH | Aripa Biotec GmbH | COVID-19-N-Antigen Schnelltest SARS-CoV-2 (vorderer Nasenabstrich) | ||
5640-S-140/21 | OFM GmbH | OFM GmbH | Deni COVID-19 Antigen Test | 133,9 | |
5640-S-036/21 | Acura Kliniken Baden-Baden GmbH | Acura Kliniken Baden-Baden GmbH | Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit | 513,35 | |
5640-S-032/21 | Shenzhen Watmind Medical Co., Ltd. | Shenzhen Watmind Medical Co., Ltd. | SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | AT-108/20 | 150 |
5640-S-049/21 | Mexacare GmbH | Mexacare GmbH | MEXACARE Corona Home-Test Antigen | 130 | |
5640-S-123/21 | Safecare Biotech (Hangzhou) Co., Ltd. | NIC GmbH | COVID-19 Antigen Rapid Test kit(Swab) (self-testing) | ||
5640-S-015/21 | Qingdao Hightop Biotech Co., Ltd. | Qingdao Hightop Biotech Co., Ltd. | HIGHTOP SARS-CoV-2 (COVID-19) Antigen Rapid Test | AT301/20 | |
5640-S-053/21 | Vitrosens Biyoteknoloji Ltd.Sti. | Vitrosens Biyoteknoloji Ltd.Sti. | RapidFor SARS-CoV-2 Rapid Antigen Test | AT507/20 | 100 |
5640-S-045/21 | nal von minden GmbH | nal von minden GmbH | NADAL® COVID-19 Ag Test | AT021/20 | 502,38 |
5640-S-216/21 | Abbott Rapid Diagnostics Jena GmbH | Abbott Rapid Diagnostics Jena GmbH | Panbio™ COVID-19 Antigen Self-Test | AT116/21 | 157,74 |
5640-S-058/21 | Anbio (Xiamen) Biotechnology Co., Ltd. | Anbio (Xiamen) Biotechnology Co., Ltd. | COVID-19 Antigen Schnelltest (Kolloidales Gold) | AT195/21 | 425 |
5640-S-156/21 | WQS Management Consultants GmbH | WQS Management Consultants GmbH | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal | ||
5640-S-171/21 | ACON Biotech(Hangzhou) Co., Ltd | ACON Biotech(Hangzhou) Co., Ltd | SARS-CoV-2-Antigenschnelltest (Selbsttest) | 160 | |
5640-S-179/21 | Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Wondfo Biotech Co., Ltd. | 2019-nCoV Antigen Test (Lateral Flow Method) | 850 | |
5640-S-031/21 | PerGrande BioTech Development Co., Ltd. | JingCheng Asia Group Limited | SARS-CoV-2 Antigen Detection Kit (Colloidal | ||
5640-S-118/21 | Bio-Gram Diagnostics GmbH | Bio-Gram Diagnostics GmbH | COVID-19 Ag Test Kit | 800 | |
5640-S-094/21 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ag Schnelltest (Kolloidales Gold) | 230 | |
5640-S-063/21 | PCL Inc. | Haemo Pharma GmbH | PCL COVID19 Ag Gold | 562 | |
5640-S-151/21 | JOINSTAR BIOMEDICAL TECHNOLOGY CO., LTD. | JOINSTAR BIOMEDICAL TECHNOLOGY CO., LTD. | COVID-19 Antigen Schnelltest (kolloidales Gold) Probenmaterial: vorderer Nasenabstrich | 100 | |
5640-S-028/21 | Icon Medlab GmbH | Icon Medlab GmbH | SARS-CoV-2 Antigen Rapid Test Kit | ||
5640-S-214/21 | Brawa GmbH | Brawa GmbH | COVID-19 (SARS-CoV-2) Antigen Schnelltest | ||
5640-S-086/21 | Anhui Deepblue Medical Technology Co. Ltd. | Anhui Deepblue Medical Technology Co. Ltd. | COVID-19 (SARS-CoV-2) Antigentest (kolloidales | 320 | |
5640-S-087/21 | Anhui Deepblue Medical Technology Co. Ltd. | Anhui Deepblue Medical Technology Co. Ltd. | COVID-19 (SARS-CoV-2) Antigentestkit (kolloidales | 320 | |
5640-S-240/21 | Joinstar Biomedical Technology Co., Ltd | Joinstar Biomedical Technology Co., Ltd | Covid-19 Antigen Rapid Test (Colloidal Gold) |