MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
Device Facts
| Record ID | K002023 |
|---|---|
| Device Name | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 |
| Applicant | Medmira Laboratories, Inc. |
| Product Code | LYR · Microbiology |
| Decision Date | Nov 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3110 |
| Device Class | Class 1 |
Regulatory Classification
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.
