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e-CFR data is current as of July 14, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5700


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


§866.5700   Whole human plasma or serum immunological test system.

(a) Identification. A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

(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 59 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001]

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