Auto Total Bilirubin Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K761218 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultra Zyme Plus Ck-1 #64978, 65027 & 28

  Class II

  FDA 510(k) K812593 Active Cleared 2 Oct 1981

• Ultrachem Phosphorus, 64973

  Class I

  FDA 510(k) K772156 Active Cleared 6 Dec 1977

• Ultrachem Total Protein, #64974

  Class II

  FDA 510(k) K772155 Active Cleared 6 Dec 1977

• Ultrazyme Plus Alp

  Class II

  FDA 510(k) K770870 Active Cleared 14 Jul 1977

• Ultra Zyme Plus Gpt, #64956, 65035 & 36

  Class I

  FDA 510(k) K812591 Active Cleared 24 Sep 1981

• Ultrazyme Alkaline Phosphatase

  Class II

  FDA 510(k) K760024 Active Cleared 26 Aug 1976

See all devices from Harleco →

• What is the Auto Total Bilirubin Reagent used for?

  This reagent is designed for clinical chemistry applications to measure bilirubin levels in plasma or serum. Bilirubin is an organic compound that is produced during the normal and abnormal destruction of red blood cells.

• What testing method does this device employ?

  The device utilizes a diazo colorimetry test system. This method is used to quantify the concentration of bilirubin present in the patient's blood sample.

• Has this device received regulatory clearance?

  Yes, the Auto Total Bilirubin Reagent manufactured by Harleco has received FDA 510(k) clearance under K761218. It is classified under regulation number 862.1110 for clinical chemistry use.