Dna-Reagents, Campylobacter Spp.
DNA reagents for Campylobacter species are nucleic acid-based diagnostic reagents used to detect Campylobacter organisms in clinical specimens through molecular techniques such as PCR, facilitating rapid diagnosis of Campylobacter-associated gastroenteritis. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQO, regulated under 21 CFR 866.3110, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LQO
- Device Class
- FDA class 1
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894712 | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION | Nov 14, 1989 | Substantially Equivalent | Gen-Probe, Inc. |
| K873670 | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | Jun 08, 1988 | Substantially Equivalent | Molecular Biosystems, Inc. |
| K875101 | VIROGEN CMV ANTIBODY TEST | Mar 01, 1988 | Substantially Equivalent | Wampole Laboratories |
| K863270 | GENE-TRAK CAMPYLOBACTER ASSAY | Aug 31, 1987 | Substantially Equivalent | Integrated Genetics |