Rickettsia Real-time PCR Assay
Device Facts
| Record ID | K170940 |
|---|---|
| Device Name | Rickettsia Real-time PCR Assay |
| Applicant | Centers For Disease Control and Prevention (CDC) |
| Product Code | PVQ · Microbiology |
| Decision Date | Jun 29, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3316 |
| Device Class | Class 2 |
Regulatory Classification
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.
