Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5765](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5765) → CZS — Retinol-Binding Protein, Antigen, Antiserum, Control

# CZS · Retinol-Binding Protein, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5765 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS

## Overview

- **Product Code:** CZS
- **Device Name:** Retinol-Binding Protein, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5765](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5765)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS/K973189.md) | RETINOL BINDING PROTEIN RBP RID KIT | The Binding Site, Ltd. | Sep 29, 1997 | SESE |
| [K955881](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS/K955881.md) | RETINOL BINDING RID KIT | The Binding Site, Ltd. | Mar 22, 1996 | SESE |
| [K853261](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS/K853261.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZS)

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