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866.3630—Serratia spp. serological reagents.
(a)
Identification. Serratia spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Serratia spp. from cultured isolates. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Serratia and provides epidemiological information on these diseases. Serratia spp. are occasionally associated with gastroenteritis (food poisoning) and wound infections.
(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.
Code of Federal Regulations
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