Identifiers
- 510(k) Number
- K123586 FDA 510(k)
- FDA Product Code
- CGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1225 FDA 510(k)
- Regulation Number
- 862.1225 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Easyra Creatinine Reagent is an alkaline picrate colorimetry reagent used for the quantitative determination of creatinine in human serum and plasma. It is designed for use on the Medica EasyRA clinical chemistry analyzer.
This reagent is supplied in bar-coded formats for use with the specified benchtop analyzer. The device is regulated under FDA 510(k) clearance as a clinical chemistry reagent.
Frequently asked questions
What is the intended use of the Easyra Creatinine Reagent?
This reagent is used for the quantitative determination of creatinine levels in human serum and plasma samples. It utilizes alkaline picrate colorimetry to provide accurate measurements for clinical diagnostic purposes.
Which equipment is compatible with this reagent?
The Easyra Creatinine Reagent is specifically designed for use on the Medica EasyRA clinical chemistry analyzer. It is supplied in bar-coded formats to ensure seamless integration and compatibility with this specific benchtop system.
What is the regulatory status of this device?
The Easyra Creatinine Reagent is regulated under FDA 510(k) clearance as a clinical chemistry reagent. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clinical chemistry analyzer - EasyRA - Medica Corporation, Medica EasyRA Reagents - JANT PHARMACAL CORPORATION, PDF June 20, 2000 - support.medicacorp.com, Reagents Medica EasyRA Clinical Chemistry Analyzer | Tek Medical Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123586 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corporation
Sources (1)
- FDA 510(k) K123586 24 fields · synced Sep 22, 2026