Ultrachem Creatinine

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770819 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Ultrachem Creatinine 64972 used for?

  The Ultrachem Creatinine 64972 is a colorimetric reagent designed to measure creatinine levels in serum or plasma samples. Creatinine is a key marker for assessing renal function, helping diagnose conditions like chronic kidney disease or acute renal failure. The reagent employs alkaline picrate chemistry to quantify creatinine concentrations accurately.

• How is the Ultrachem Creatinine 64972 supplied and for what analyzer is it intended?

  This reagent is supplied as a kit specifically for use with the Centrifuchem analyzer, a semi-automated clinical chemistry system. It is intended for in vitro diagnostic use in laboratory settings, ensuring compatibility with this analyzer for reliable creatinine measurements.

• Is the Ultrachem Creatinine 64972 single-use or reusable?

  The Ultrachem Creatinine 64972 is designed for single-use only. This ensures consistency in test results and reduces the risk of cross-contamination or degradation of reagent quality over repeated use.

• Are there any specific storage conditions or shelf life details provided for this reagent?

  The provided data does not specify storage conditions or shelf life for the Ultrachem Creatinine 64972. Laboratories should follow standard practices for reagent storage, typically involving cool, dry environments away from direct light, until further details are confirmed by the manufacturer.

• What regulatory clearance does the Ultrachem Creatinine 64972 hold?

  The Ultrachem Creatinine 64972 has received FDA 510(k) clearance under product code CGX, indicating it is substantially equivalent to a predicate device. This clearance is relevant for clinical chemistry applications and was filed under the Clinical Chemistry advisory committee.