PVQ · Rickettsia Spp. Nucleic Acid Based Detection Assay
Microbiology · 21 CFR 866.3316 · Class 2
Overview
| Product Code | PVQ |
|---|---|
| Device Name | Rickettsia Spp. Nucleic Acid Based Detection Assay |
| Regulation | 21 CFR 866.3316 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
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 Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170940 | Rickettsia Real-time PCR Assay | Centers For Disease Control and Prevention (CDC) | Jun 29, 2017 | SESE |
Top Applicants
- Centers For Disease Control and Prevention (CDC) — 1 clearance
