Liqui Zyme Total Bilirubin Reagent

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

510(k) Number

K840564 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the LIQUI ZYME Total Bilirubin Reagent used for?

  The LIQUI ZYME Total Bilirubin Reagent is a clinical chemistry reagent used for the colorimetric determination of total bilirubin in human serum or plasma using the diazo method. It is intended for in vitro diagnostic use in clinical laboratories.

• How is the LIQUI ZYME Total Bilirubin Reagent supplied?

  The reagent is supplied as a single-use product and requires appropriate storage conditions as specified by the manufacturer. It is classified as a Class II medical device for in vitro diagnostic use in clinical laboratories.

• What is the regulatory status of the LIQUI ZYME Total Bilirubin Reagent?

  The device has received FDA 510(k) clearance with K number K840564 and is regulated under product code CIG, which corresponds to 21 CFR 862.1110 for clinical chemistry laboratory devices. It is classified as a Class II medical device.

• Is the LIQUI ZYME Total Bilirubin Reagent reusable or single-use?

  The LIQUI ZYME Total Bilirubin Reagent is supplied as a single-use product. It is not designed for reuse and should be handled according to the manufacturer's instructions for proper storage and disposal.