HCG Midstream Test, Individually Pouched, Bulk Expires: 10-18-2017

Product Code: 8041300001
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HCG Midstream Test, Individually Pouched, Bulk Expires: 10-18-2017


HCG MIDSTREAM TEST, INDIVIDUALLY POUCHED, BULK

INTENDED USE
One-Step Urine Pregnancy Midstream Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.

One-Step Urine Pregnancy Midstream Test is a qualitative, sandwich dye conjugate immunoassay for the determination of human hCG in urine. 4.5 The method employs a combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity. In less than 5 minutes, elevated levels of hCG equal to or greater than 25 mIU/mL can be detected.

FEATURES

    In less than 5 minutes, elevated levels of hCG equal to or greater than 25 mIU/mL can be detected.
    Tests Urine
    FDA 510k & CLIA WAIVED
    Built-in control system
    Shelf-life up to 18-24 months


TEST PROCEDURE

    To begin testing, open the sealed pouch by tearing along the notch. Remove test kit from the pouch.
    Hold the round end of cover with one hand. Use the other hand to pull out the test device and expose the absorbent.
    Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 seconds.
    Re-cap the device and wait for colored bands to appear.


Do not stream past the arrow end

INTERPRETATION OF RESULTS

    Negative: Only one color band appears on the control region. No apparent band on the test region. There is no pregnancy.
    Positive: Distinct color bands appear on the control and test regions. Both test line and control line indicates that you are pregnant. Color intensity of the test bands may vary. Different stages of pregnancy have different concentrations of hCG hormone.
    Invalid: No visible band at all. Repeat test with a new test kit.


STORAGE AND STABILITY

The test kit can be stored at temperatures between 2 to 30°C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

PRECAUTION

    For in vitro diagnostic use only.
    Do not use test kit beyond expiry date.
    The test device should not be reused.

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