In Vitro Gammacoat B-Hcg Radio. Test

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

510(k) Number

K823313 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Gammadab Lh Radio-Kit #ca-1508

  Class I

  FDA 510(k) K823476 Active Cleared 28 Dec 1982

• In Vitro T-3 Uptake Test

  Class II

  FDA 510(k) K770480 Active Cleared 6 Apr 1977

• Gastrin Radioimmunoassay Test

  Class I

  FDA 510(k) K810722 Active Cleared 27 May 1981

• Ria Kit, Gammacoat

  Class II

  FDA 510(k) K782109 Active Cleared 26 Jan 1979

• IV Vitro Gammadab T4 Ria Kit

  Class II

  FDA 510(k) K781235 Active Cleared 14 Aug 1978

• In Vitro T3 Ria Test

  Class II

  FDA 510(k) K772108 Active Cleared 17 Nov 1977

See all devices from Clinical Assays, Inc. →

• What is the GammaCoat B-HCG Radioassay Test used for?

  This test is designed for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or plasma samples. It aids in diagnosing pregnancy and evaluating certain gynecological conditions by detecting and quantifying hCG levels using a solid-phase radioimmunoassay technique with gamma-coated tubes. The results help clinicians confirm or monitor pregnancy status and related conditions.

• How is the GammaCoat B-HCG Radioassay Test supplied, and is it reusable?

  The test is supplied as a complete kit for in vitro diagnostic use in clinical chemistry laboratories. Each kit contains all necessary reagents and components for performing the assay. It is intended for single-use only, meaning each kit should not be reused after a single test. No additional sterilization is required beyond the manufacturer-provided packaging.

• Is sterilization required for this test kit?

  No, sterilization beyond the manufacturer-provided packaging is not required. The kit is designed for single-use and is supplied in a way that ensures sterility for one use only. Always follow the manufacturer’s instructions for handling and storage to maintain integrity.

• What regulatory approval does this test hold?

  The GammaCoat B-HCG Radioassay Test holds FDA 510(k) clearance (K823313) under the Clinical Chemistry advisory committee. It is classified as a Class II device and is intended for prescription use only. The clearance indicates it is deemed substantially equivalent to a predicate device, meeting regulatory standards for safety and effectiveness.

• How should the GammaCoat B-HCG Radioassay Test be stored?

  Storage and handling of this test kit follow standard in vitro diagnostic protocols as specified by the manufacturer. The kit should be stored in a clean, dry environment, protected from extreme temperatures and direct light. Always refer to the manufacturer’s instructions for precise storage conditions, including temperature ranges and expiration details, to ensure accurate and reliable test results.