RETINOL BINDING RID KIT

• 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

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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