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Innovita HCG Pregnancy Rapid Combo Test

by Innovita (Tangshan) Biological Technology Co., Ltd.

510(k) K241919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241919 Date2 Aug 2024ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 26 Sep 2026

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

The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow sandwich immunochromatographic assay used for the qualitative detection of HCG in human urine or serum. It is designed for healthcare professionals, including those at point of care settings. The device consists of a single-use cassette.

This test is supplied as a single-use device and is not intended for reuse. It is authorized for use in clinical chemistry applications and has received FDA 510(k) clearance. The device is manufactured by Innovita (Tangshan) Biological Technology Co., Ltd. and is regulated under product code JHI.

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See all devices from Innovita (Tangshan) Biological Technology Co., Ltd. →

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Innovita HCG Pregnancy Rapid Combo Test used for?

    The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow sandwich immunochromatographic assay designed for the qualitative detection of HCG in human urine or serum. It is specifically intended for healthcare professionals, including those at point of care settings.

  • Is the Innovita HCG Pregnancy Rapid Combo Test a single-use device?

    Yes, the Innovita HCG Pregnancy Rapid Combo Test is supplied as a single-use device and is not intended for reuse. Each cassette should be used only once for accurate test results.

  • What regulatory authorization does the Innovita HCG Pregnancy Rapid Combo Test have?

    The Innovita HCG Pregnancy Rapid Combo Test has received FDA 510(k) clearance and is regulated under product code JHI. It is authorized for use in clinical chemistry applications.

  • How is the Innovita HCG Pregnancy Rapid Combo Test supplied?

    The test is supplied as a single-use cassette format. It is designed for healthcare professionals and can be used in point of care settings for convenient and rapid testing of HCG levels in urine or serum samples.