LQO · Dna-Reagents, Campylobacter Spp.
Microbiology · 21 CFR 866.3110 · Class 1
Overview
| Product Code | LQO |
|---|---|
| Device Name | Dna-Reagents, Campylobacter Spp. |
| Regulation | 21 CFR 866.3110 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K894712 | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION | Gen-Probe, Inc. | Nov 14, 1989 | SESE |
| K873670 | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | Molecular Biosystems, Inc. | Jun 8, 1988 | SESE |
| K875101 | VIROGEN CMV ANTIBODY TEST | Wampole Laboratories | Mar 1, 1988 | SESE |
| K863270 | GENE-TRAK CAMPYLOBACTER ASSAY | Integrated Genetics | Aug 31, 1987 | SESE |
Top Applicants
- Gen-Probe, Inc. — 1 clearance
- Integrated Genetics — 1 clearance
- Molecular Biosystems, Inc. — 1 clearance
- Wampole Laboratories — 1 clearance
