RANDOX PREALBUMIN
Device Facts
| Record ID | K000661 |
|---|---|
| Device Name | RANDOX PREALBUMIN |
| Applicant | Randox Laboratories, Ltd. |
| Product Code | JZJ · Immunology |
| Decision Date | Apr 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5060 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
