LQP · Campylobacter Spp.
Microbiology · 21 CFR 866.3110 · Class 1
Overview
| Product Code | LQP |
|---|---|
| Device Name | 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210976 | Curian Campy | Meridian Bioscience, Inc. | Dec 23, 2021 | SESE |
| K211342 | Sofia 2 Campylobacter FIA | Quidel Corporation | Nov 23, 2021 | SESE |
| K191456 | Campylobacter Quik Chek | Techlab, Inc. | Jun 20, 2019 | SESE |
| K191442 | Campylobacter Chek | Techlab, Inc. | Jun 20, 2019 | SESE |
| K173219 | CAMPYLOBACTER CHEK | Techlab, Inc. | Jan 22, 2018 | SESE |
| K173217 | CAMPYLOBACTER QUIK CHEK | Techlab, Inc. | Jan 22, 2018 | SESE |
| K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | Meridian Bioscience, Inc. | May 28, 2009 | SESE |
| K083464 | PREMIER CAMPY, MODEL 618096 | Meridian Bioscience, Inc. | Jan 30, 2009 | SESE |
| K982315 | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY | Alexon - Trend, Inc. | Nov 18, 1998 | SESE |
| K880389 | MERITEC(TM)-CAMPY (JCL) | Meridian Diagnostics, Inc. | Apr 12, 1988 | SESE |
| K864027 | BBL CAMPYSLIDE(TM) TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 11, 1986 | SESE |
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Institute Virion , Ltd. | Sep 30, 1986 | SESE |
Top Applicants
- Techlab, Inc. — 4 clearances
- Meridian Bioscience, Inc. — 3 clearances
- Alexon - Trend, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Institute Virion , Ltd. — 1 clearance
