Contact Us I  Home I 

 

31 New York Avenue

Framingham, MA 01701

800-332-1042

www.genzymediagnostics.com I  www.usdiagcustomerservice@genzyme.com

 

COMPANY DESCRIPTION

 

Genzyme Diagnostics through its partners and distributors offers a novel line of products for the diagnostics industry and the clinical laboratory. Working together, the Genzyme Diagnostics team is committed to quality products and customer satisfaction.

 

PRODUCTS

 

OSOM® hCG Urine   I   OSOM® hCG Combo   I   OSOM® Card Pregnancy   I   OSOM® Strep A
OSOM® Ultra Strep A (25)   I    OSOM® Ultra Strep A (50)   I   OSOM® Mono   I   OSOM® Trichomonas Rapid Test
OSOM® ImmunoDip® Urinary Albumin Test   I   OSOM® BVBLUE®    I   OSOM® Influenza A&B

 
OSOM hCG Urine

  • CLIA Classification -
    Waived

  • Analytes performed
    on this device - Urine

  • CPT Code associated
    with each analyte - 81025

  • Test methodology –
    Immunochromatographic dipstick

  • Sample volume –
    Urine in cup to dipstick
    sample line (8mm)

  • Time to result –
    5 minutes

  • Units in which the test is reported –
    Positive or Negative

  • MSDS

OSOM hCG Combo

  • CLIA Classification -
    Waived for Urine

  • Analytes performed on this device – Urine or Serum

  • CPT Code associated
    with each analyte – Urine – 81025  Serum - 84703

  • Test methodology – Immunochromatographic
    assay

  • Sample volume – 135uL

  • Time to result –
    3 minutes for Urine - 
    5 minutes for Serum

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

 OSOM Card Pregnancy

  • CLIA Classification -
    Waived

  • Analytes performed on this device - Urine

  • CPT Code associated
    with each analyte - 81025

  • Test methodology – Immunochromatographic
    assay

  • Sample volume – 135uL

  • Time to result –
    3 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Strep A

  • CLIA Classification -
    Waived

  • Analytes performed on this device – Throat swab

  • CPT Code associated
    with each analyte - 87880

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Throat swab provided with kit

  • Time to result –
    5 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Ultra Strep A (25)

  • CLIA Classification -
    Waived

  • Analytes performed on this device – Throat swab

  • CPT Code associated with
    each analyte - 87880

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Throat swab provided with kit

  • Time to result –
    5 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Ultra Strep A (50)

  • CLIA Classification -
    Waived

  • Analytes performed on this device – Throat swab

  • CPT Code associated with each analyte - 87880

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Throat swab provided with kit

  • Time to result –
    5 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Mono

  • CLIA Classification –
    Whole Blood Waived

  • Analytes performed on this device – Whole Blood, Serum or plasma

  • CPT Code associated with each analyte - 86308

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Capillary tube for whole blood or 1 drop serum or plasma

  • Time to result –
    5 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Trichomonas

Rapid Test

  • CLIA Classification -
    Waived

  • Analytes performed on this device – Vaginal Swab

  • CPT Code associated with each analyte - 87808

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Vaginal Swab provided with kit

  • Time to result –
    10 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM ImmunoDip Urinary Albumin Test

  • CLIA Classification -
    Waived

  • Analytes performed on this device - Urine

  • CPT Code associated
    with each analyte - 83518

  • Test methodology – Immunochromatographic
    test strip

  • Sample volume –
    Urine in cup to dipstick
    sample line

  • Time to result –
    3 minutes

  • Units in which the test is reported - Positive or Negative

  • MSDS

OSOM BVBLUE

  • CLIA Classification -
    Waived

  • Analytes performed on this device – Vaginal Swab

  • CPT Code associated with each analyte - 87905

  • Test methodology – Sialidase enzyme assay

  • Sample volume –
    Vaginal Swab provided with kit

  • Time to result –
    10 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

OSOM Influenza A&B

  • CLIA Classification –
    Moderately complex

  • Analytes performed on this device – Nasal Swab

  • CPT Code associated
    with each analyte - 87804

  • Test methodology – Immunochromatographic dipstick

  • Sample volume –
    Nasal Swab and 2 extra tests for QC  included in kit

  • Time to result –
    10 minutes

  • Units in which the test is reported -
    Positive or Negative

  • MSDS

 

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