FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380213851
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH33225
Catalog number
CH33225
Device description
Cardinal Health Covid-19/Flu A&B Rapid Test
Published
2026-11-02
Public version status
New
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
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
K251538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251538000Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.2025-11-14SCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380213852PackageGS120In Commercial Distribution
20885380213851PrimaryGS10
10885380213854Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538021385250885380213852
2088538021385120885380213851
1088538021385410885380213854

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
25
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253025316Monoject888151123588815112352021-09-17
20884521014999Monoject888151131088815113102016-09-24
20884521014937Monoject888151111088815111102016-09-24
10192253046526Kendall55546BAMD55546BAMD2023-10-09
10192253046786Kendall55588BAMDX55588BAMDX2025-09-09
10885380031687PROTEXIS2D72NT65X2D72NT65X2018-04-13
10192253025309Monoject888151120188815112012021-09-17
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00323900051317VicksPROCTER & GAMBLE MANUFACTURING COMPANY, THESCA2026-10-26
00323900051324VicksPROCTER & 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