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
| Device Type ID | 3583 |
| Device Name | Rickettsia Spp. Nucleic Acid Based Detection Assay |
| Physical State | In Vitro Diagnostic Devices That Consist Of Reagents And Associated Instrumentation For The Detection And Identification Of Rickettsia Spp. Nucleic Acids In Human Clinical Specimens. |
| Technical Method | Qualitative In Vitro Diagnostic Assay That Detects And Identifies Rickettsia Spp. Nucleic Acids In Human Clinical Specimens. |
| Target Area | Clinical Specimens From Patients Suspected Of Infection With Rickettsia Spp. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3316 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PVQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3583 |
| Device | Rickettsia Spp. Nucleic Acid Based Detection Assay |
| Product Code | PVQ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3316 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |