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Pregnancy hCG Midstream Urine Test (Qty 5)

Pregnancy hCG Midstream Urine Test (Qty 5)


Item Number: FPMS-5
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Product Description
Now CLIA Waived! K Number in CLIA Database is K112101.

FDA Approved and Doctors recommended Pregnancy Test. The most sensitive rapid pregnancy test for the early pregnancy detection.

Product Description:

  • Detects elevated levels of Human Chorionic Gonadotropin (hCG)
  • hCG hormone level in the human body doubles approximately every 2.2 days during the first trimester
  • Simple, accurate & inexpensive urine test
  • FDA Cleared & CLIA Waived
  • Easy to read and understand results, with 99% accuracy

Instructions:

  • Remove the test device from the sealed pouch and use it as soon as possible.
  • Remove the protection cap.
  • Take the test at the assigned handle and hold the absorbent wick into the urine stream for 10-15 seconds.
  • Read results in 3 minutes. Do not interpret test result after 10 minutes 

 

Drug cut-off:
hCG 20 MIU/mL

 

Results: 

Not Pregnant: Only one colored line appears in the square window. This line is just the control line (C).

Pregnant: Two red colored lines are visible; one line in the round test window (T) Test region, and a second line in the square window (C) Control region. The color intensity of the test line may be weaker or stronger than that of the control line.

INVALID: No line appears in the control region (C). Under no circumstances should a positive sample be identified until the control line forms.

 

Additional Information:

    Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception (1-4). hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period (2-4), and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the hCG One Step Pregnancy Test Strip (Urine) shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.

    • The test is CLIA Waived indicating the test is certified accurate and designed to eliminate mistakes during home use.


    To see the graphic procedure card for the testing step by step advice, CLICK HERE



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