21 CFR 866.3250 — Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3250
Identification
Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used in serological tests to identify Erysipelothrix rhusiopathiae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Erysipelothrix. This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GSD | Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae | 1 | 0 | |
| GSE | Antiserum, Erysipelothrix Rhusiopathiae | 1 | 0 | |
| GSF | Antigen, Erysipelothrix Rhusiopathiae | 1 | 0 |
