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e-CFR data is current as of July 10, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5430


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§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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