ANTISERUM TO HUMAN PREALBUMIN
Device Facts
| Record ID | K850686 |
|---|---|
| Device Name | ANTISERUM TO HUMAN PREALBUMIN |
| Applicant | Kent Laboratories, Inc. |
| Product Code | JZJ · Immunology |
| Decision Date | Nov 1, 1985 |
| 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.
