Definition: A Qualitative In Vitro Diagnostic Assay Intended To Detect Chlamydophila Pneumoniae DNA Extracted From Human Respiratory Specimens. Detection Of Chlamydophila Pneumoniae DNA Aids In The Diagnosis Of Chlamydophila Pneumoniae Respiratory Infection In C
| Device Type ID | 3551 |
| Device Name | Chlamydophila Pneumoniae Dna Assay System |
| Physical State | Chlamydophila Pneumoniae DNA Detection Assay Systems Are Devices That Consist Of Reagents And Instruments For The Detection Of Chlamydophila Pneumoniae DNA Extracted From Human Respiratory Specimens. |
| Technical Method | A Qualitative In Vitro Diagnostic Assay Intended To Chlamydophila Pneumoniae DNA Extracted From Human Respiratory Specimens. |
| Target Area | In Vitro Diagnostic Assay |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |