Unifast Calcium Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864661 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the intended use of the Unifast Calcium Test?

  This device is designed to measure total calcium levels in serum. It is intended to assist clinicians in the diagnosis and treatment of conditions such as parathyroid disease, bone diseases, chronic renal disease, and tetany.

• What chemical method does this test employ?

  The Unifast Calcium Test utilizes cresolphthalein complexone to determine the concentration of calcium in a patient's serum sample.

• Is this device regulated by the FDA?

  Yes, the Unifast Calcium Test is regulated under FDA 510(k) clearance K864661. It is classified as a Class 2 medical device under regulation number 862.1145.