21 CFR § 866.3720 - spp. exoenzyme reagents.

---
identifier: "/us/cfr/t21/s866.3720"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3720 - spp. exoenzyme reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3720"
section_name: "spp. exoenzyme reagents."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.3720 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]