Definition: Device To Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens.
| Device Type ID | 3587 |
| Device Name | Lower Respiratory Microbial Nucleic Acid Detection System |
| Physical State | In Vitro Diagnostic Device Consisting Of Reagents And Associated Instrumentation For Detection Of Nucleic Acid Sequences From Microorganisms And Associated Resistance Markers In Lower Respiratory Specimens. |
| Technical Method | In Vitro Diagnostic Device That Detects And Identifies Nucleic Acid Sequences From Microorganisms And Associated Resistance Markers In Lower Respiratory Specimens. |
| Target Area | Respiratory Specimens From Patients With Signs And Symptoms Of Respiratory Infection. |
| 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 | 866.3985 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3587 |
| Device | Lower Respiratory Microbial Nucleic Acid Detection System |
| Product Code | QBH |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3985 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |