Assay, Direct, Nucleic Acid Amplification, Q Fever
OVF is the FDA product code for Assay, Direct, Nucleic Acid Amplification, Q Fever, a class I device type, regulated under 21 CFR 866.3500. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OVF
- Device name
- Assay, Direct, Nucleic Acid Amplification, Q Fever
- FDA 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.
- Regulation
- 21 CFR 866.3500
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OVF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2011 | 1 |
Applicants with the most clearances
Product code OVF| Applicant | Clearances |
|---|---|
| Idaho Technology, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OVF.
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