Coated Tube HCG Immunoassay HCG

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

510(k) Number

K841023 ↗

FDA Product Code

JHI

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 Ventrex Laboratories, Inc. →

• What is the COATED TUBE HCG IMMUNOASSAY HCG used for?

  This device is used for the visual detection of human chorionic gonadotropin (hCG) in urine specimens. It is an in vitro diagnostic test system intended for prescription use in clinical laboratory settings to aid in pregnancy testing.

• How is the COATED TUBE HCG IMMUNOASSAY HCG supplied and is it sterile or reusable?

  The device is supplied as a non-sterile, single-use in vitro diagnostic test system. It is designed for one-time use only and should not be reused, as reuse could compromise test accuracy and increase contamination risk.

• What regulatory pathway was used for the COATED TUBE HCG IMMUNOASSAY HCG and when was it cleared?

  The device received traditional 510(k) clearance (K841023) from the FDA on May 1, 1984, and is substantially equivalent to a legally marketed predicate device. This clearance pathway confirms its safety and effectiveness for the intended use.