FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380200844
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH1032
Catalog number
CH1032
Device description
Cardinal Health Brand Influenza A and B Dipstick Test Kit
Published
2024-08-02
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
PSZDevices detecting influenza A, B, and C virus antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380200845PackageGS118In Commercial Distribution
20885380200844PrimaryGS10
10885380200847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538020084550885380200845
2088538020084420885380200844
1088538020084710885380200847

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
961027315
Device count
25
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00742860100413Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
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00742860100475Acucy System Universal DrawerSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
50885380200845CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestLumos Diagnostics, Inc.PSZ2023-11-30
00848838027031Remel REMEL, INC.PSZ2021-11-12
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
10743816001553Status™ COVID-19/FluPRINCETON BIOMEDITECH CORPORATIONPSZ2021-02-15
00742860100390OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
10742860100397OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100338Acucy SystemSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100345Acucy Calibration DeviceSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100383Acucy Influenza A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-23
00742860100376Acucy Flu Test KitSEKISUI DIAGNOSTICS, LLCPSZ2019-08-20
10811877010972BinaxNOW Influenza A & B Card 2Alere Scarborough, Inc.PSZ2019-07-15
10811877010989BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.PSZ2019-07-15
00895160002526Fluoro-CheckTM Influenza A+BNANO-DITECH CORPORATIONPSZ2019-05-24
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.PSZ2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.PSZ2018-10-29
10854916006796MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
10854916006802MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
00382902560715BD Veritor™ System CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYPSZ2018-05-25
00840733101649ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate KitMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12
00840733101656ImmunoCard STAT! FLU A&BMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12