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Electronic Code of Federal Regulations

e-CFR data is current as of October 10, 2019

Title 21Chapter ISubchapter HPart 866Subpart D → §866.3720


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents


§866.3720   Streptococcus spp. exoenzyme reagents.

(a) Identification. Streptococcus spp. exoenzyme reagents are devices used to identify antibodies to Streptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney 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 38792, July 25, 2001]

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