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Electronic Code of Federal Regulations

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter HPart 866Subpart E → §866.4100


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart E—Immunology Laboratory Equipment and Reagents


§866.4100   Complement reagent.

(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of 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, 2001, as amended at 66 FR 38792, July 25, 2001]

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