FDA.reportPublic FDA data

McKesson

Primary DI
20612479279715
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
35235
Device description
HCG Dipsticks
Published
2025-09-10
Public version status
New
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
DHASystem, Test, Human Chorionic Gonadotropin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479279715PrimaryGS10
10612479279701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247927971520612479279715
1061247927970110612479279701

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.

Regulatory Flags#

DUNS number
023904428
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740106003ARCHITECTABBOTT IRELANDDHA2025-12-12
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
10612479280172McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740215712AlinityABBOTT LABORATORIESDHA2025-10-08
10758750034291VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
20758750034298VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
07613336217535Elecsys HCG+ betaRoche Diagnostics GmbHDHA2024-06-03
06947145578039MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06925912718703iFlash-HCGShenzhen YHLO Biotech Co., Ltd.DHA2024-01-30
00695684893019Pregcolor PlusGERMAINE LABORATORIES, INCDHA2023-08-09
00695684971014Pregcolor Premium GERMAINE LABORATORIES, INCDHA2023-08-09
04987270235232Lumipulse G BHCG Immunoreaction CartridgesFUJIREBIO INC.DHA2023-02-01
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
07613336169216Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
07613336169223Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
00695684957018Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
06956848940166Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
00380740160623AlinityABBOTT IRELANDDHA2019-04-10
00816862021639PreviewWONDFO USA CO., LTD.DHA2019-03-06
00816870020570Free B-hCG XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020587Free B-hCG XR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020921hCG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020938Monobind AccuBind hCG ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020945hCG Extended Range AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020952hCG Extended Range AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022253Monobind AccuLite Free B-hCG XR CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022260Monobind AccuLite Free B-hCG XR CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022581Monobind AccuLite hCG CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11