FDA.reportPublic FDA data

McKesson

Primary DI
00612479269880
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
RSV001
Device description
RSV Antigen Test (12/kt, 48kt/cs)
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021789000QUICKLAB RSVIntegrated Biotechnology Corp.2002-11-20GQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479269897PackageGS148In Commercial Distribution
00612479269880PrimaryGS10
00612479269873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479269897006124792698976124792698970612479269897
00612479269880006124792698806124792698800612479269880
00612479269873006124792698736124792698730612479269873

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from respiratory syncytial virus (RSV) in a clinical specimen.

Regulatory Flags#

DUNS number
023904428
Device count
20
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950921308096CLUNGENEHangzhou Clongene Biotech Co., Ltd.GQG2026-04-11
00742860100666OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
10742860100663OSOM RSV Test HomeSEKISUI DIAGNOSTICS, LLCGQG2025-05-19
20612479277278McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
40612479277289McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2025-05-14
00810160810377Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00810160810360Red TunicaRodimedi & Associates, Inc.GQG2025-03-14
00612479269897McKessonMCKESSON MEDICAL-SURGICAL INC.GQG2024-09-09
00895160002854Nano-Check RSV TestNANO-DITECH CORPORATIONGQG2024-08-08
05032384502950IMAGEN Respiratory Syncytial Virus (RSV)OXOID LIMITEDGQG2024-06-19
10722066008031Rapid ResponseBTNX IncGQG2024-02-21
00722066008034Rapid ResponseBTNX IncGQG2024-02-21
08033891327668CHORUS RESPIRATORY SYNCYTIAL VIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGQG2024-01-22
10694644700036Easy Lab Pro RSVAMERICAN BIO MEDICA CORPORATIONGQG2023-01-12
00840733101847TRU RSVMERIDIAN BIOSCIENCE, INC.GQG2020-12-09
00840733101977FLU/RSV Positive ControlMERIDIAN BIOSCIENCE, INC.GQG2020-11-17
10811877010484BinaxNOW Nasopharyngeal Swab Accessory KitAlere Scarborough, Inc.GQG2020-09-16
10811877011160BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011177BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011184BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011191BinaxNOW RSVAlere Scarborough, Inc.GQG2020-09-16
10811877011207BinaxNOW RSV Control Swab KitAlere Scarborough, Inc.GQG2020-09-16
30014613201939QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202226QuickVueQUIDEL CORPORATIONGQG2018-11-10
30014613202424SofiaQUIDEL CORPORATIONGQG2018-11-10
30014613202608SofiaQUIDEL CORPORATIONGQG2018-11-10
00382902560388BD Veritor™ System For Rapid Detection of RSV - CLIA waived kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
00382902560425BD Veritor™ System For Rapid Detection of RSV - Laboratory kitBECTON, DICKINSON AND COMPANYGQG2018-05-25
10627966005183RAMP® RSV TEST KIT; 25 TESTSResponse Biomedical CorpGQG2017-08-31
10627966005206RAMP® RSV Control SwabsResponse Biomedical CorpGQG2017-08-31