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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5530


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


§866.5530   Immunoglobulin G (Fc fragment specific) immunological test system.

(a) Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

(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 the limitations in §866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]

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