CLIAwaived, Inc. Pregnancy Tests (25 Cassettes)


(25 Tests)

The CLIAwaived, Inc. Pregnancy Test (Cassette), 7mm hCG Top, is a rapid one step visual test for the qualitative detection of human chorionic gonadotropin hCG at 25mIU/mL in urine. FDA Cleared and CLIA Waived. (FDA 510K#: K984076)

The CLIAwaived, Inc. Pregnancy Test (Cassette) is a qualitative immunoassay for the detection of human chorionic gonadatropin (hCG) in human urine for the early detection of pregnancy. hCG is a hormone produced by the placenta, which, in normal subjects, provides an early indication of pregnancy. Early testing and detection of hCG is vital for the health of mother and child, and to deliver reliable diagnostic information on which health care professionals can base optimal patient management strategies.


  • Simple one-step test
  • Room temperature storage
  • Built-in procedural control
  • Fast results in 5 minutes or less
  • User-friendly, reliable, accurate
  • FDA-cleared and CLIA-waived
  • CPT Code: 81025 - Pregnancy Test Kits Urine Qualitative
Product Insert (72.93 kB)
Sales Flyer (1.24 MB)
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