FDA.reportPublic FDA data

CVS Health

Primary DI
00050428029923
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
641986
Device description
CVS Health Covid/ Flu Combo Test (2 PACK)
Published
2025-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00050428029923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428029923000504280299230504280299230050428029923

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062312574
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestAccess Bio Inc.SCA2026-06-08
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 LAB 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
10895160002967Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
00850078377098iHealthiHealth Labs Inc.SCA2026-01-02
00850078377104iHealthiHealth Labs Inc.SCA2026-01-02
00850078377128iHealthiHealth Labs Inc.SCA2026-01-02
00850078377135iHealthiHealth Labs Inc.SCA2026-01-02
10850078377095iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377101iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377125iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377132iHealthIHEALTH LAB INC.SCA2026-01-02
00850010224381CareSuperb COVID-19/FluA&B Antigen Combo Home TestAccess Bio Inc.SCA2025-12-24
10612479277936McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
40612479277944McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
00810107290224Flowflex Plus RSV + Flu A/B + COVID Home TestAcon Laboratories, Inc.SCA2025-11-06
30014613340751QuickVue™ WONDFO USA CO., LTD.SCA2025-10-31