BEUDAMED
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    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    hCG Rapid Test Cassette 25 mIU/mL

    FDA UDI
    ACRO BIOTECH INC·00853691007670·hCG Rapid Test Cassette 25 mIU/mL

    hCG Rapid Test Midstream 25 mIU/mL

    FDA UDI
    ACRO BIOTECH INC·00853691007687·hCG Rapid Test Midstream 25 mIU/mL

    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.

    FDA Enforcement
    Class II ·Terminated·Alere San Diego, Inc.·June 5, 2013

    hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL

    FDA UDI
    ACRO BIOTECH INC·00853691007694·Pregnancy (hCG) Enhanced Sensitivity Rapid Test...

    hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL

    FDA UDI
    ACRO BIOTECH INC·00853691007229·hCG Enhanced Sensitivity Rapid Test Cassette 10...

    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JHI·April 16, 2013

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·February 16, 2024

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·February 16, 2024

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 29, 2008

    ARCHITECT ANTI-HBS

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·November 20, 2025

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·December 2, 2010

    ALINITY I TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 14, 2024

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·March 31, 2025

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·March 31, 2025

    ALINITY I ANTI-HBS REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·November 18, 2024

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2024

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2024

    ARCHITECT I1000SR PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·May 14, 2025

    ALINITY I ANTI-HBS REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·December 23, 2024