HCG Screening Test

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K830156 ↗

FDA Product Code

JHJ

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ra Screening Test

  Class II

  FDA 510(k) K830611 Active Cleared 24 Mar 1983

• Tago Fiffu-Gen, Orosomucoid

  Class I

  FDA 510(k) K841734 Active Cleared 1 Jun 1984

• Diffu-Gen Haptoglobin Radial Immuno

  Class II

  FDA 510(k) K840404 Active Cleared 9 Mar 1984

• Mono Screening Test

  Class II

  FDA 510(k) K830531 Active Cleared 17 Mar 1983

• Diffu-Gen Apolipoprotein a-I Radial -

  Class I

  FDA 510(k) K834218 Active Cleared 11 May 1984

• Tago Diffu-Gen-Apolipoprotein B-100

  Class I

  FDA 510(k) K833129 Active Cleared 21 Nov 1983

See all devices from Tago, Inc. →

• What is the HCG Screening Test used for?

  The HCG Screening Test is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples to determine pregnancy status. It utilizes an agglutination method and is intended for screening purposes in clinical chemistry applications.

• How is the HCG Screening Test supplied and can it be reused?

  The HCG Screening Test is supplied as a point-of-care testing device and is specifically designed for single-use only. It should not be reused or repurposed after initial use to ensure accurate test results and maintain safety standards.

• What sizes and models are available for the HCG Screening Test?

  The HCG Screening Test is available in various sizes and models as specified by the manufacturer, Tago, Inc. The specific configurations and options would be detailed in the product documentation provided by the manufacturer.

• How should the HCG Screening Test be stored?

  The HCG Screening Test should be stored according to the manufacturer's instructions to maintain its integrity and functionality. Proper storage conditions would be outlined in the product documentation provided by Tago, Inc.

• What is the regulatory status of the HCG Screening Test?

  The HCG Screening Test has received FDA 510(k) clearance with the product code JHJ. It is classified under clinical chemistry applications and is considered substantially equivalent to predicate devices in this category.