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K Number
K955881
Device Name
RETINOL BINDING RID KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1996-03-22

(85 days)

Product Code
CZS
Regulation Number
866.5765
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 866.5765 Retinol-binding protein immunological test system.

(a)
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.(b)
Classification. 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.