FDA.reportPublic FDA data

Vicks

Primary DI
00323900051324
Brand
Vicks
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
83942945
Device description
Vicks RapidTest FLU A + FLU B + COVID-19 Antigen Combo Home Test 2 count
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00323900051324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00323900051324003239000513243239000513240323900051324

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
004238200
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00323900051317Vicks839429442026-10-26
00073010720091TampaxTampax Radiant Regular, Radiant Pocket Regular, Pe2026-06-25
00073010720831TampaxTampax Pearl Super, Regular, Triple Pak - Super, R2026-06-25
00073010721173TampaxTampax Pearl Super, Super Plus, Ultra2026-06-25
00073010721210This is LThis is L Organic Regular, Super2026-06-25
00073010721227TampaxTampax Pearl Regular, Super2026-06-25
00073010721272TampaxTampax Pearl Triple Pak - Super, Super Plus, Ultra2026-06-25
00073010721333This is LThis is L Organic Super, Super Plus2026-06-25
00073010721340TampaxTampax Pearl Super, Regular PDQ2026-06-25
00073010721517This is LThis is L Organic Super, Super plus2026-06-25
00073010721524This is LThis is L Organic Triple Pak - Regular, Super, Sup2026-06-25
00073010721616This is LThis is L Organic Regular, Super2026-06-25
00073010721623This is LThis is L Organic Regular, Super2026-06-25
00073010721685TampaxTampax Pearl Super, Regular, Super Plus PDQ2026-06-25
00073010721807TampaxTampax Pearl Super, Regular Floorstand2026-06-25
00073010721845TampaxTampax Radiant Sidecap2026-06-25
00073010721906TampaxTampax Pearl Super, Regular Pallet2026-06-25
00073010721968TampaxTampax Pearl Super, Regular, Compact Floorstand2026-06-25
00047400703117Braun Silk.expert Pro 5PL51002026-01-05
00047400703230Braun Silk.expert Pro 5PL54422026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00323900051317VicksPROCTER & GAMBLE MANUFACTURING COMPANY, THESCA2026-10-26
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