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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR866.5430]
See Related Information on Beta-2-glycoprotein I immunological test system. in CDRH databases



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. 866.5430 Beta-2-glycoprotein I immunological test system.

(a) Identification. A beta -2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta -2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta -2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.

(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 2312, Jan. 14, 2000]

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