FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380181198
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH24
Catalog number
CH24
Device description
Cardinal Health hCG Combo Cassette
Published
2022-02-22
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
JHIVisual, pregnancy hCG, prescription use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380181198PrimaryGS10
10885380181191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538018119820885380181198
1088538018119110885380181191

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
25
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06970640093103INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.JHI2026-04-15
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-04-09
00810164510105Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-02-12
00816862027723HORMONElife™WONDFO USA CO., LTD.JHI2026-01-15
10850082766007QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00850082766000QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00816862028157HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
00816862028119HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
20612479280148McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479280162McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280134McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280158McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479279722MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
20612479279739McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279855MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
00661392055650LSL HEALTHCARELSL Industries, LLCJHI2025-06-06
06952062778165HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
56952062778160HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
20197344024992MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10197344024995MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
00816862023787PreviewWONDFO USA CO., LTD.JHI2023-08-03