21 CFR 866.5765 — Retinol-Binding Protein, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5765
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CZS | Retinol-Binding Protein, Antigen, Antiserum, Control | 1 | 3 |
