Diagnostics Alkaline Phosphatase Optimi

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

510(k) Number

K823213 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Diagnostics Alkaline Phosphatase Optimi used for?

  This reagent is designed for the quantitative measurement of alkaline phosphatase activity in serum or plasma samples. Clinicians use it to assess liver function, evaluate bone metabolism, and diagnose metabolic disorders by quantifying enzyme activity through a colorimetric assay.

• How is the Diagnostics Alkaline Phosphatase Optimi supplied and intended for use?

  The reagent is supplied as a liquid for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use applications and requires standard laboratory handling procedures. No additional preparation or special handling beyond typical reagent storage is specified.

• Is sterility or MRI safety information provided for this reagent?

  The manufacturer does not provide specific sterility assurances or MRI safety information for the Diagnostics Alkaline Phosphatase Optimi. Storage and handling should follow general reagent stability guidelines outlined in the manufacturer’s specifications.

• What are the key specifications or regulatory details for this product?

  The reagent falls under FDA regulation 862.1050 and was cleared via a 510(k) submission (K823213) in 1982, classified as substantially equivalent to prior devices. It is categorized under Clinical Chemistry and is intended for use in measuring alkaline phosphatase activity via a colorimetric assay.

• How should this reagent be stored?

  Storage conditions align with typical reagent stability guidelines as outlined by the manufacturer. While specific details are not provided in the data, it is generally recommended to follow the manufacturer’s instructions for optimal performance and shelf life.