21 CFR 866.3110 — Antiserum, Fluorescent, Campylobacter Fetus
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3110
Identification
Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GSP | Antiserum, Fluorescent, Campylobacter Fetus | 1 | 0 | 3rd Party |
| LQO | Dna-Reagents, Campylobacter Spp. | 1 | 4 | 3rd Party |
| LQP | Campylobacter Spp. | 1 | 12 | 3rd Party |
| LYR | Helicobacter Pylori | 1 | 91 | 3rd Party |
| MSQ | Test, Urea (Breath Or Blood) | 1 | 17 | 3rd Party |
| OWF | Immunohistochemical Assay, Helicobacter Pylori | 1 | 1 | 3rd Party |
| OZA | Test, Urea Adult And Pediatric (Breath), | 3 | 2 |
