21 CFR 866.3500 — Antiserum, Fluorescent, Q Fever
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3500
Identification
Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GPJ | Antiserum, Fluorescent, Q Fever | 1 | 2 | |
| GPK | Antiserum, Rickettsial Pox | 1 | 0 | |
| GPM | Antiserum, Murine Typhus Fever | 1 | 1 | |
| GPN | Antiserum, Typhus Fever | 1 | 1 | |
| GPO | Antigen, Cf, Typhus Fever Group | 1 | 1 | |
| GPP | Antiserum, Rocky Mountain Spotted Fever | 1 | 1 | |
| GPQ | Antigen, Cf, Spotted Fever Group | 1 | 0 | |
| GPR | Antiserum, Cf, Q Fever | 1 | 0 | |
| GPS | Antigen, Cf, Q Fever | 1 | 1 | |
| LSQ | Reagent, Rickettsia Serological | 1 | 4 | |
| OVF | Assay, Direct, Nucleic Acid Amplification, Q Fever | 1 | 1 |
