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e-CFR data is current as of July 9, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5765


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§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.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

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