part_subject: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
subpart_code: "D"
subpart_subject: "Serological Reagents"
section_number: "866.3065"
section_subject: "
"
cfr_reference: "21 CFR 866.3065"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(a)Identification. Bordetella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, used in serological tests to identify Bordetella spp. from cultured isolates or directly from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Bordetella and provides epidemiological information on these diseases. Bordetella spp. cause whooping cough (Bordetella pertussis) and other similiarly contagious and acute respiratory infections characterized by pneumonitis (inflammation of the lungs).
(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.