21 C.F.R. § 866.5040 Albumin immunological test system.
Title 21 - Food and Drugs
(a) Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (b) Classification. Class II (special 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 63 FR 59227, Nov. 3, 1998]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5040 Albumin immunological test system.
