Now Home Pregn. Test Kit Enzyme Immunoassay Hcg

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K850079 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Bioclinical Systems, Inc. →

• What is the NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG used for?

  This device is used to qualitatively detect human chorionic gonadotropin (hCG) in urine as an indication of pregnancy. It is designed for home use by consumers without a prescription, providing a rapid result based on the presence of hCG, a hormone produced by the placenta after conception.

• How is the NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG supplied and is it reusable?

  The kit is supplied as a single-use, over-the-counter device intended for individual use only. It is not reusable and must be discarded after one test to ensure accuracy and prevent contamination, as it is packaged in a sterile condition for one-time application.

• What storage conditions are required for the NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG?

  The device should be stored at room temperature to maintain test stability and performance. No refrigeration or special handling is required, making it suitable for convenient home storage until the expiration date indicated on the packaging.