Wiener Lab. Creatinina Cinetica Aa
510(k) K012065
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012065 | Date10 Oct 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JFY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
This device is an enzymatic method for creatinine measurement in clinical chemistry, as defined by its device name and classification. It is a reagent-based assay designed to quantify creatinine in human serum, plasma, and urine samples using an alkaline picrate colorimetric method, where creatinine reacts with picrate under alkaline conditions to form a measurable creatinine-picrate complex.
The device is supplied as a liquid reagent for use with clinical chemistry analyzers, such as the Metrolab 2300 plus, and requires associated calibrators and quality control materials for proper operation. It is intended for in vitro diagnostic use in laboratory settings and has received FDA 510(k) clearance under product code JFY, with regulation number 862.1225, indicating substantial equivalence to a legally marketed predicate device.
Other devices from Wiener Laboratories Saic
Questions
AI-generated answers, 25 Sep 2026
What is the WIENER LAB. CREATININA CINETICA AA used for?
This device is an enzymatic method reagent designed to quantify creatinine in human serum, plasma, and urine samples. It uses an alkaline picrate colorimetric method where creatinine reacts with picrate under alkaline conditions to form a measurable creatinine-picrate complex, enabling in vitro diagnostic use in clinical chemistry laboratories.
How is the WIENER LAB. CREATININA CINETICA AA supplied and what is required for its use?
The device is supplied as a liquid reagent intended for use with clinical chemistry analyzers, such as the Metrolab 2300 plus. It requires associated calibrators and quality control materials for proper operation and is designed for in vitro diagnostic use in laboratory settings.
Is the WIENER LAB. CREATININA CINETICA AA a single-use or reusable reagent?
As a liquid reagent for enzymatic creatinine measurement, this device is intended for single-use in diagnostic testing. Reagents are consumed during the assay process and must be replenished for each test run, consistent with standard clinical chemistry reagent usage patterns.