Definition: A Qualitative In Vitro Diagnostic Assay Intended To Detect Mycoplasma Pneumoniae DNA Extracted From Human Respiratory Specimens. Detection Of Mycoplasma Pneumoniae DNA Aids In The Diagnosis Of Mycoplasma Pneumoniae Respiratory Infection In Conjunctio
| Device Type ID | 3550 |
| Device Name | Mycoplasma Pneumoniae Dna Assay System |
| Physical State | Mycoplasma Pneumoniae DNA Detection Assay Systems Are Devices That Consist Of Reagents And Instruments For The Detection Of Mycoplasma Pneumoniae DNA Extracted From Human Respiratory Specimens. |
| Technical Method | A Qualitative In Vitro Diagnostic Assay Intended To Detect Mycoplasma 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) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3550 |
| Device | Mycoplasma Pneumoniae Dna Assay System |
| Product Code | OZX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| CFR Regulation Number | 866.3980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MERIDIAN BIOSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIDIAN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |