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Eq-Prc Lc Warfarin Genotyping Kit

by Trimgen Corporation 510(k)

Active United States

510(k) K073071

Overview

The Eq-Prc Lc Warfarin Genotyping Kit is a diagnostic tool used to identify genetic polymorphisms in patients that affect their response to warfarin, a common anticoagulant. It is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The kit helps clinicians predict the optimal warfarin dosage for individual patients, minimizing the risk of adverse effects.

The Eq-Prc Lc Warfarin Genotyping Kit is supplied for use in clinical laboratories and is authorized with an FDA 510K clearance. The device is classified as a Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System, with a product code of ODW and a regulation number of 862.3360.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073071 Date6 Feb 2009ClearedStatusActive

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
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ODW
Device Class
Class II
Regulation
21 CFR Part 862.3360
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the EQ-PRC LC Warfarin Genotyping Kit used for?

    The EQ-PRC LC Warfarin Genotyping Kit is used to identify genetic polymorphisms in patients that affect their response to warfarin, a common anticoagulant, to predict the optimal warfarin dosage and minimize adverse effects.

  • Is the EQ-PRC LC Warfarin Genotyping Kit supplied sterile?

    The description does not explicitly state that the kit is supplied sterile, but it is intended for use in clinical laboratories, where proper handling and preparation would be expected to ensure sterility.

  • What is the regulatory status of the EQ-PRC LC Warfarin Genotyping Kit?

    The EQ-PRC LC Warfarin Genotyping Kit has been authorized with an FDA 510K clearance, indicating that it has been found to be substantially equivalent to a predicate device.

  • How is the EQ-PRC LC Warfarin Genotyping Kit classified?

    The EQ-PRC LC Warfarin Genotyping Kit is classified as a Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System, with a product code of ODW and a regulation number of 862.3360.