Tandem Qualitative HCG Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812461 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Tandem Icon II Hcg Immunoenzymetric Assay Kit

  Class II

  FDA 510(k) K860542 Active Cleared 5 Mar 1986

• Tandem-E Lh Immunoenzymetric Assay Kit

  Class I

  FDA 510(k) K895094 Active Cleared 31 Oct 1989

• Tandem-E Thyroid Stimulating Hormone Kit

  Class II

  FDA 510(k) K832813 Active Cleared 31 Oct 1983

• TANDEM M-PAK PAP Immunoenzymetric Assay

  Class II

  FDA 510(k) K864945 Active Cleared 5 Jan 1987

• Tandem-E -Fer Immunoenzymetric Kit

  Class II

  FDA 510(k) K823871 Active Cleared 25 Feb 1983

• Photon Immunoassay Analyzer

  Class I

  FDA 510(k) K832364 Active Cleared 26 Aug 1983

See all devices from Hybritech, Inc. →

• What is the Tandem Qualitative HCG Kit used for?

  The Tandem Qualitative HCG Kit is designed to detect the presence of human chorionic gonadotropin (HCG) in urine samples, confirming pregnancy through a qualitative assay. HCG is a hormone produced during pregnancy, and this device provides a simple, rapid visual result to aid in early pregnancy detection in clinical settings like hospitals, clinics, and laboratories.

• How is the Tandem Qualitative HCG Kit supplied and intended for use?

  The kit is supplied as a single-use diagnostic tool intended exclusively for prescription use in clinical chemistry settings. It is not intended for home or over-the-counter use. Each kit is meant for one-time use only, ensuring accuracy and sterility for a single test.

• Does the Tandem Qualitative HCG Kit require special storage conditions?

  No special storage conditions are required beyond standard laboratory practices. The kit should be stored in a way that maintains its integrity and usability, such as in a clean, dry environment away from direct sunlight or extreme temperatures, following typical clinical laboratory protocols.

• Is the Tandem Qualitative HCG Kit reusable or single-use?

  The Tandem Qualitative HCG Kit is designed for single-use only. This ensures reliability, sterility, and accuracy for each test, preventing cross-contamination or degradation of results from repeated use.

• What regulatory approval does the Tandem Qualitative HCG Kit hold?

  The Tandem Qualitative HCG Kit holds FDA 510(k) clearance under the product code JHI, with the clearance number K812461. It is classified as a Class II medical device under special controls and is intended for use in clinical chemistry settings as a prescription-only diagnostic tool.