McKesson
Model CCOVAg-PNMB · MCKESSON MEDICAL-SURGICAL INC. · DI 20612479285747
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 — MCKESSON MEDICAL-SURGICAL INC.
- NAI 2016-03-03 McKesson Medical-Surgical Inc · 0 citations
- NAI 2012-05-01 McKesson Medical-Surgical Inc. · 0 citations
- NAI 2011-12-08 McKesson Medical-Surgical · 2 citations