Definition: These Reagents Are Nucleic Acid Primers And Probes Intended For The Amplification And Identification Of Coxiella Burnetii Directly From Clinical Specimens. The Identification Aids In The Diagnosis Of Q Fever And Provides Epidemiological Information O
| Device Type ID | 3542 |
| Device Name | Assay, Direct, Nucleic Acid Amplification, Q Fever |
| Physical State | A Kit That Contains Reagents And An Instrument That Measures Flourescence. |
| Technical Method | The Q Fever Assay Uses A Real-time Thermocycler. A Real-time Thermocycler Is Intended To Identify And/or Quantify The Presence Of Specific Sequences Of Double Stranded DNA, Amplified From A Biological Source And Labeled With Fluorescently Labeled Pro |
| Target Area | Blood |
| Regulation Description | Rickettsia Serological Reagents. |
| 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 | 866.3500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OVF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |