Definition: A Qualitative In Vitro Diagnostic Assay Intended To Detect Bordetella Pertussis DNA Extracted From Human Respiratory Specimens. Detection Of Bordetella Pertussis DNA Aids In The Diagnosis Of Bordetella Pertussis Respiratory Infection In Conjunction W
| Device Type ID | 3552 |
| Device Name | Bordetella Pertussis Dna Assay System |
| Physical State | Bordetella Pertussis DNA Detection Assay Systems Are Devices That Consist Of Reagents And Instruments For The Detection Of Bordetella Pertussis DNA Extracted From Human Respiratory Specimens. |
| Technical Method | A Qualitative In Vitro Diagnostic Assay Intended To Bordetella Pertussis 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 | OZZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3552 |
| Device | Bordetella Pertussis Dna Assay System |
| Product Code | OZZ |
| 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 | |
DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GREAT BASIN SCIENTIFIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIDIAN BIOSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIDIAN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |