LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
Device Facts
| Record ID | K853261 |
|---|---|
| Device Name | LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) |
| Applicant | Behring Diagnostics, Inc. |
| Product Code | CZS · Immunology |
| Decision Date | Aug 22, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5765 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A retinol-binding protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the retinol-binding protein that binds and transports vitamin A in serum and urine. Measurement of this protein may aid in the diagnosis of kidney disease and in monitoring patients with kidney transplants.
