Home GUDID 20612479285747 McKesson
Primary DI 20612479285747
Brand McKesson
Company MCKESSON MEDICAL-SURGICAL INC.
Model CCOVAg-PNMB
Device description COVID-19 Antigen Control Kit (10 swabs per box)
Published 2026-06-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 40612479285758 Package GS1 30 In Commercial Distribution 20612479285747 Primary GS1 0 10612479285955 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 40612479285758 40612479285758 20612479285747 20612479285747 10612479285955 10612479285955
GMDN Terms# Term, Definition table Term Definition Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
Regulatory Flags# DUNS number 023904428 Device count 10 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20612479285723 McKesson MCKESSON MEDICAL-SURGICAL INC. QVF 2026-06-18 00816862028416 WELLlife™ WONDFO USA CO., LTD. QVF 2026-06-01 00742860100673 OSOM COVID-19 Test Sekisui Diagnostics, LLC QVF 2026-01-19 10742860100670 OSOM COVID-19 Test SEKISUI DIAGNOSTICS, LLC QVF 2026-01-19 00382902560920 BD Veritor System for Rapid Detection of SARS-CoV-2 BECTON, DICKINSON AND COMPANY QVF 2025-08-21 30382902560921 BD Veritor System for Rapid Detection of SARS-CoV-2 BECTON, DICKINSON AND COMPANY QVF 2025-08-21 B379COVAF201 SCoV-2 Ag Detect™ Rapid Test INBIOS INTERNATIONAL, INC QVF 2024-09-13 B379COVAF501 SCoV-2 Ag Detect™ Rapid Test INBIOS INTERNATIONAL, INC QVF 2024-09-13 30014613339755 Sofia 2 QUIDEL CORPORATION QVF 2023-03-28