SCoV-2 Ag Detect™ Rapid Test
Model COVAF-20 · INBIOS INTERNATIONAL, INC · DI B379COVAF201
QVF — Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings · Class II · 21 CFR 866.3982
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — INBIOS INTERNATIONAL, INC
- VAI 2022-06-16 InBios International, Inc. · 4 citations
- VAI 2022-06-16 InBios International, Inc. · 4 citations
- VAI 2018-08-23 InBios International, Inc. · 4 citations
- VAI 2018-08-23 InBios International, Inc. · 4 citations
- NAI 2015-05-15 InBios International, Inc. · 0 citations
- NAI 2015-05-15 InBios International, Inc. · 0 citations
- VAI 2013-04-22 InBios International, Inc. · 1 citations
- VAI 2013-04-22 InBios International, Inc. · 1 citations
- VAI 2012-05-04 InBios International, Inc. · 14 citations
- VAI 2012-05-04 InBios International, Inc. · 14 citations
- NAI 2010-08-27 InBios International, Inc. · 0 citations
- NAI 2010-08-27 InBios International, Inc. · 0 citations