Auto-Total Bilirubin Reag for Gilford AN

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

510(k) Number

K761027 ↗

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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See all devices from Harleco →

• What is the Auto-Total Bilirubin Reag for Gilford AN used for?

  The Auto-Total Bilirubin Reag for Gilford AN is a Class II medical device used for the measurement of bilirubin levels in clinical chemistry testing. It is intended for use in clinical chemistry laboratories to help diagnose and monitor conditions related to bilirubin levels.

• What is the regulatory status of this device?

  This device was cleared by the FDA on November 30, 1976 under 510(k) number K761027. It is classified as a Class II medical device under the product code CIG for Diazo Colorimetry, Bilirubin and is subject to special controls.

• How is the Auto-Total Bilirubin Reag supplied and what are its specifications?

  The device is manufactured by Harleco and is supplied as a reagent for use with the Gilford AN analyzer. It is designed for the colorimetric measurement of bilirubin using the diazo method, which is a standard technique in clinical chemistry laboratories for quantifying bilirubin concentrations.

• Is this device single-use or reusable?

  The Auto-Total Bilirubin Reag for Gilford AN is a reagent product, which typically means it is consumed during the testing process and not intended for reuse. The reagent is designed to be used with the Gilford AN analyzer for bilirubin measurements in clinical chemistry testing.