Hichem Calcium Reagent Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K981794 ↗

FDA Product Code

CJY

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Hichem Diagnostics →

• What is the Hichem Calcium Reagent Kit used for?

  The Hichem Calcium Reagent Kit is an in vitro diagnostic reagent designed for total calcium measurement in serum, plasma, and urine samples. It utilizes the arsenazo III method where calcium reacts with arsenazo III to form a blue complex, with absorbance measured at 650 nm.

• How is the Hichem Calcium Reagent Kit supplied?

  The device is supplied as a reagent kit intended for single-use in clinical chemistry laboratories. It is designed to be used with clinical analyzers or through manual spectrophotometric procedures for calcium measurement.

• What is the regulatory status of the Hichem Calcium Reagent Kit?

  The Hichem Calcium Reagent Kit is FDA 510(k) cleared with product code CJY and regulation number 862.1145. It is classified as class II and deemed substantially equivalent, having received FDA clearance on July 29, 1998.

• What method does the Hichem Calcium Reagent Kit use for measurement?

  The kit utilizes the arsenazo III method, where calcium in the sample reacts with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is measured either through a clinical analyzer or manual spectrophotometric procedure.