Tandem HCG Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K820822 ↗

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 HCG Kit used for?

  The Tandem HCG Kit is a qualitative visual immunoassay designed to detect human chorionic gonadotropin (HCG) in urine samples. HCG is a hormone produced during pregnancy, so its presence can help confirm pregnancy status. This device is intended for use in clinical chemistry settings by trained personnel, such as healthcare providers, and is not for home or over-the-counter use.

• How is the Tandem HCG Kit supplied and is it reusable?

  The Tandem HCG Kit is supplied as a single-use diagnostic tool. Each kit is intended for one-time use only and must not be reused. This ensures accuracy and maintains sterility, as reuse could compromise the integrity of the test results and pose risks to patient safety.

• Is the Tandem HCG Kit sterile and how should it be stored?

  The Tandem HCG Kit is designed for single-use in clinical settings, where sterility is maintained through proper handling and storage. It should be stored in a cool, dry place, away from direct sunlight and extreme temperatures. Follow manufacturer guidelines for packaging to preserve its performance until use.

• What regulatory approval does the Tandem HCG Kit have?

  The Tandem HCG Kit holds FDA 510(k) clearance (K820822) as a Class II medical device under special controls. This clearance confirms that the device meets FDA requirements for safety and effectiveness as a prescription-use visual pregnancy test in clinical chemistry settings.

• Are there different models or sizes available for the Tandem HCG Kit?

  The provided data does not specify multiple models or sizes for the Tandem HCG Kit. It is listed under the product code JHI and appears as a standardized single-use device for clinical pregnancy testing. For exact specifications, refer to the manufacturer’s documentation or contact Hybritech, Inc.