In-Vitro Test Determination Total Bilirubin

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

510(k) Number

K854180 ↗

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 In-Vitro Test Determination Total Bilirubin used for?

  This device is used for the measurement of total bilirubin levels in vitro to aid in the diagnosis and monitoring of hyperbilirubinemia and hepatobiliary diseases resulting from various acquired or inherited disorders of bilirubin metabolism and hemolysis in patients.

• Is this device single-use or reusable?

  The In-Vitro Test Determination Total Bilirubin is supplied as a single-use product and is not intended for MRI environments. It should be used according to the manufacturer's instructions and discarded after a single use.

• What is the regulatory status of this device?

  This device is regulated under FDA 510(k) clearance with product code CIG and device class 2. It has been determined to be substantially equivalent to other devices in this category.

• How should this device be stored?

  The device should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information, so users should refer to the product documentation for proper storage requirements.