§862.1645. Urinary protein or albumin (nonquantitative) test system.
21 C.F.R. § 862.1645
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]