FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020244
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-21
Catalog number
B1077-21
Device description
hCG Dipstick Rapid Test
Published
2016-09-01
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
50885380020245PackageGS140In Commercial Distribution
20885380020244PrimaryGS10
10885380020247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538002024550885380020245
2088538002024420885380020244
1088538002024710885380020247

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 Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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