Home GUDID 10612479279855 Mckesson
Primary DI 10612479279855
Brand Mckesson
Company MCKESSON MEDICAL-SURGICAL INC.
Model 35035
Device description hCG Serum/Urine Tests
Published 2025-08-14
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 Code Name JHI Visual, Pregnancy Hcg, Prescription Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20612479279722 Primary GS1 0 10612479279855 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20612479279722 20612479279722 10612479279855 10612479279855
GMDN Terms# Term, Definition table Term Definition Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical A 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 35 DM exempt false Premarket exempt false HCT/P false Kit false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06936983113793 Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum) Hangzhou AllTest Biotech Co., Ltd. JHI 2026-04-22 06936983113809 Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum) Hangzhou AllTest Biotech Co., Ltd. JHI 2026-04-22 06970640093103 INNOVITA Innovita (Tangshan) Biological Technology Co., Ltd. JHI 2026-04-15 10673486014020 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test TECO DIAGNOSTICS JHI 2026-04-09 00810164510105 Atida hCG Pregnancy Rapid Combo Test ACESO LABORATORIES INC. JHI 2026-03-23 80810164510101 Atida hCG Pregnancy Rapid Combo Test ACESO LABORATORIES INC. JHI 2026-03-23 10673486014006 Teco Diagnostics One-Step Pregnancy Dipstick Test TECO DIAGNOSTICS JHI 2026-02-12 00816862027723 HORMONElife™ WONDFO USA CO., LTD. JHI 2026-01-15 10850082766007 QMedix™ Diagnostic Automation, Inc. JHI 2025-12-24 00850082766000 QMedix™ Diagnostic Automation, Inc. JHI 2025-12-24 00816862028157 HORMONElife™ WONDFO USA CO., LTD. JHI 2025-12-15 00816862028119 HORMONElife™ WONDFO USA CO., LTD. JHI 2025-12-15 20612479280148 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-12-10 20612479280162 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-12-10 10612479280134 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-12-10 10612479280158 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-12-10 20612479279722 Mckesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-08-14 20612479279739 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-08-14 10612479279862 McKesson MCKESSON MEDICAL-SURGICAL INC. JHI 2025-08-14 00661392055650 LSL HEALTHCARE LSL Industries, LLC JHI 2025-06-06 06952062778165 HCG Home Use Pregnancy Test Midstream (Colloidal Gold) ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD JHI 2025-02-12 56952062778160 HCG Home Use Pregnancy Test Midstream (Colloidal Gold) ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD JHI 2025-02-12 10673486002454 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test TECO DIAGNOSTICS JHI 2024-12-19 00850054026651 QMedix™ Diagnostic Automation, Inc. JHI 2024-06-25 20197344024992 Medline MEDLINE INDUSTRIES, INC. JHI 2024-03-11 10197344024995 Medline MEDLINE INDUSTRIES, INC. JHI 2024-03-11 10673486002409 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test TECO DIAGNOSTICS JHI 2024-01-16 10673486002379 TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TEST TECO DIAGNOSTICS JHI 2023-10-26 00816862023787 Preview WONDFO USA CO., LTD. JHI 2023-08-03 00816862023800 Wondfo WONDFO USA CO., LTD. JHI 2023-08-03