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Ventrex Pregnancy Test Kit Enzyme

by Vxr, Inc. 510(k)

Active United States

510(k) K833960

Overview

The Ventrex Pregnancy Test Kit Enzyme is a clinical chemistry device used for detecting human chorionic gonadotropin (hCG) in urine specimens to determine pregnancy status. This enzyme-based test provides visual results for prescription use in clinical settings.

The device is supplied as a single-use test kit and is classified under product code JHI with FDA 510(k) clearance K833960. It is regulated under 862.1155 and is intended for use in clinical chemistry laboratories. No information regarding sterility, MRI safety, or storage conditions is provided in the device data.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833960 Date3 Feb 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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

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Questions

  • What is the Ventrex Pregnancy Test Kit Enzyme used for?

    The Ventrex Pregnancy Test Kit Enzyme is a clinical chemistry device used for detecting human chorionic gonadotropin (hCG) in urine specimens to determine pregnancy status. It provides visual results for prescription use in clinical settings.

  • How is the Ventrex Pregnancy Test Kit Enzyme supplied?

    The device is supplied as a single-use test kit. It is classified under product code JHI with FDA 510(k) clearance K833960 and is regulated under 862.1155 for use in clinical chemistry laboratories.

  • Is the Ventrex Pregnancy Test Kit Enzyme sterile?

    No information regarding sterility is provided in the device data. The test kit is designed for single-use in clinical settings, but specific details about sterility are not included in the available information.

  • What are the regulatory requirements for the Ventrex Pregnancy Test Kit Enzyme?

    The device has FDA 510(k) clearance K833960 and is classified under product code JHI. It is regulated under 862.1155 and is intended for prescription use in clinical chemistry laboratories. The device is classified as substantially equivalent.