Skip to content

Human Chorionic Gonadotropin Visual Test Kit

by Disease Detection International, Inc. 510(k)

Active United States

510(k) K880410

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880410 Date5 Apr 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Human Chorionic Gonadotropin Visual Test Kit is a diagnostic device classified as a pregnancy HCG test system, designed to detect human chorionic gonadotropin (HCG) in urine or plasma. HCG is a hormone produced during pregnancy, and its presence can confirm early pregnancy. This visual test kit provides a qualitative result, typically through a colorimetric reaction, to indicate the presence or absence of HCG.

The kit is intended for single-use in clinical or home settings, supplied as a prescription-use device. It requires no special storage conditions beyond standard room temperature and is regulated under FDA 510(k) clearance (K880410) as a Class II device. The device is intended for use in clinical chemistry laboratories or by authorized healthcare professionals, adhering to regulatory standards for diagnostic accuracy and safety.

Other devices from Disease Detection International, Inc.

See all devices from Disease Detection International, Inc. →