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Total Bilirubin For Demand Analyzer

by Advanced Biomedical Methods, Inc. 510(k)

Active United States

510(k) K844243

Overview

The Total Bilirubin for Demand Analyzer is a clinical chemistry reagent used for the quantitative determination of bilirubin in human serum. It is designed for use with the Demand Analyzer system to support routine biochemical testing.

This device is supplied by Advanced Biomedical Methods, Inc. and has received FDA 510(k) clearance under K844243. It is classified under regulation number 862.1145 for use in clinical chemistry settings.

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 NumberK844243 Date3 Jan 1985ClearedStatusActive

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
CIC
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the intended use of the Total Bilirubin for Demand Analyzer?

    This reagent is intended for the quantitative determination of bilirubin levels in human serum. It is specifically designed to be used in conjunction with the Demand Analyzer system to facilitate routine biochemical testing in clinical chemistry settings.

  • What is the regulatory status of this reagent?

    The Total Bilirubin for Demand Analyzer has received FDA 510(k) clearance under K844243. It is classified under regulation number 862.1145 for use as a clinical chemistry device.

  • Which system is required to use this bilirubin reagent?

    This reagent is specifically formulated for use with the Demand Analyzer system. It is not intended for use as a standalone diagnostic tool but rather as a component of the Demand Analyzer's routine biochemical testing workflow.