Pregnancy Test Urine Cards ProAdvantage CLIA Wai .. . .

188-1-2036
      
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Pregnancy Test Urine Cards ProAdvantage CLIA Waived (25/BX 10BX/CS)
Sold by: BX OF 25

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Rally #188-1-2036
Pro Advantage #P080063
hCG Pregnancy Tests
Includes 25 Individually Packaged Urine hCG Pregnancy Cassette Devices & Droppers (25/BX)

Features
• >99% Sensitivity; >99% Specificity
• 25 mlU/mL minimum hCG detection level
• Accurate results in 3 minutes for urine and 5 minutes for serum
• CLIA waived for urine and FDA 510(k) cleared to market

The Urine Pregnancy Cassette Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including mouse monoclonal anti- hCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific colored antibody conjugates and form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.



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