FDA.reportPublic FDA data

McKesson

Primary DI
10612479277936
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
535-PN2
Device description
COVID-19/Flu A&B Antigen Test External Controls
Published
2025-12-03
Public version status
New
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
SCAMulti-Analyte Respiratory Virus Antigen Detection Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240029000Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen2024-10-07SCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479277944PackageGS1200In Commercial Distribution
10612479277936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247927794440612479277944
1061247927793610612479277936

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testingA 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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479288496McKesson16-SN1C2905ST2026-10-08
20612479288526McKesson16-SN05C2905ST2026-10-08
20612479288557McKesson16-SN1C2805ST2026-10-08
20612479288588McKesson16-SN1C2558ST2026-10-08
10612479285993McKessonEXT-STND-070-0652026-10-06
10612479286013McKessonEXT-SM-030-0802026-10-06
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850078377392iHealthiHealth Labs Inc.SCA2026-10-21
10850078377408iHealthiHealth Labs Inc.SCA2026-10-21
10850078377439iHealthiHealth Labs Inc.SCA2026-10-21
10850078377477iHealthiHealth Labs Inc.SCA2026-10-21
00742860100697OSOM COVID-19 / Flu A&B Combo TestSekisui Diagnostics, LLCSCA2026-10-16
00311917086521WalgreensWALGREEN CO.SCA2026-09-28
00811877012566BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00811877012573BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00811877012580BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00811877012597BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00811877012603BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00811877012610BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-08-14
00087701190810Good Neighbor PharmacyAmerisourcebergen Drug CorporationSCA2026-07-08
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestAccess Bio Inc.SCA2026-06-08
10850078377187iHealthiHealth Labs Inc.SCA2026-05-15
00850078377180iHealthiHealth Labs Inc.SCA2026-05-15
00850078377272iHealthiHealth Labs Inc.SCA2026-05-15
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00311917077598WalgreensWALGREEN CO.SCA2026-04-28
00050428373927CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDSCA2026-04-27
00840733101557statID Pro COVID-19/Flu External ControlsMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00840733101564statID Pro COVID-19/Flu A&BMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
00850078377227iHealthiHealth Labs Inc.SCA2026-01-30
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
10850078377224iHealthiHealth Labs Inc.SCA2026-01-30
10197344173587MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
20197344173584MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
00895160002960Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16