Roche Standards for Uric Acid

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843112 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the intended use of Roche Standards for Uric Acid?

  It is intended for the quantitative determination of uric acid in human serum, plasma, and urine on cobas c systems as a secondary calibrator in clinical chemistry.

• How is Roche Standards for Uric Acid supplied and for what use?

  The device is supplied as a diagnostic reagent for in vitro use, meaning it is designed to be used outside the body in a laboratory setting to calibrate uric acid measurements.

• What regulatory authorization does Roche Standards for Uric Acid have?

  It is authorized under FDA 510(k) clearance K843112 and is classified as a Class II medical device with product code JIT under regulation number 862.1150.