IQ/QCA Total Bilirubin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K874261 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the IQ/QCA Total Bilirubin device used for?

  The IQ/QCA Total Bilirubin is a Class 2 Chemistry device designed for diazo colorimetry bilirubin testing in clinical chemistry applications. It is manufactured by BD Becton Dickinson Vacutainer Systems Preanalytic and is intended for use in clinical settings.

• Is the IQ/QCA Total Bilirubin device single-use or reusable?

  The IQ/QCA Total Bilirubin is supplied as a single-use product, meaning it is designed for one-time use only and should not be reused for patient testing to ensure accurate results and maintain safety standards.

• What is the regulatory status of the IQ/QCA Total Bilirubin device?

  The device is regulated under FDA 510(k) clearance K874261 with a decision date of 1987-11-25. It is classified under regulation number 862.1110 and is classified as a Class 2 Chemistry device with product code CIG.

• Who manufactures the IQ/QCA Total Bilirubin device?

  The IQ/QCA Total Bilirubin device is manufactured by BD Becton Dickinson Vacutainer Systems Preanalytic, located at 1 Becton Dr., Franklin Lakes, NJ 07417, United States.