GTA · Antisera, All, Serratia Marcesans
Microbiology · 21 CFR 866.3630 · Class 1
Overview
| Product Code | GTA |
|---|---|
| Device Name | Antisera, All, Serratia Marcesans |
| Regulation | 21 CFR 866.3630 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Classification Rationale
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
