CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR866.5630]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

Subpart F - Immunological Test Systems

Sec. 866.5630 Beta-2-microglobulin immunological test system.

(a) Identification. A beta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

(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 the limitations in § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]