PVQ — Rickettsia Spp. Nucleic Acid Based Detection Assay Class II
FDA product code PVQ covers "Rickettsia Spp. Nucleic Acid Based Detection Assay", a Class II medical device regulated under 21 CFR 866.3316. 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
- PVQ
- Device Class
- Class II
- Regulation Number
- 866.3316
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170940 | centers for disease control and prevention (cdc) | Rickettsia Real-time PCR Assay | June 29, 2017 |