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e-CFR data is current as of May 4, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1645


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1645   Urinary protein or albumin (nonquantitative) test system.

(a) Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

(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 §862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

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