PVQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rickettsia Spp. Nucleic Acid Based Detection Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3316
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Rickettsia Real-time PCR Assay (K170940) | Centers For Disease Control and Prevention (CDC) | 2017-06-29 |
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