OVF — Assay, Direct, Nucleic Acid Amplification, Q Fever Class I
FDA product code OVF covers "Assay, Direct, Nucleic Acid Amplification, Q Fever", a Class I medical device regulated under 21 CFR 866.3500. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OVF
- Device Class
- Class I
- Regulation Number
- 866.3500
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K103207 | idaho technology | JBAIDS Q FEVER DETECTION KIT | May 20, 2011 |