CZS · Retinol-Binding Protein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5765 · Class 1
Overview
| Product Code | CZS |
|---|---|
| Device Name | Retinol-Binding Protein, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5765 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973189 | RETINOL BINDING PROTEIN RBP RID KIT | The Binding Site, Ltd. | Sep 29, 1997 | SESE |
| K955881 | RETINOL BINDING RID KIT | The Binding Site, Ltd. | Mar 22, 1996 | SESE |
| K853261 | LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) | Behring Diagnostics, Inc. | Aug 22, 1985 | SESE |
Top Applicants
- The Binding Site, Ltd. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
