Fungal Organisms, Nucleic Acid-based Assay
Device Code: 3559
Product Code(s):
PEO Definition: A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.
Device Classification Information
| Device Type ID | 3559 |
| Device Name | Fungal Organisms, Nucleic Acid-based Assay |
| Physical State | Reagent Kit |
| Technical Method | Multiplexed Nucleic Acid-based Assay |
| Target Area | N/A |
| Regulation Description | Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures. |
| 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 | 866.3365 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3559 |
| Device | Fungal Organisms, Nucleic Acid-based Assay |
| Product Code | PEO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures. |
| CFR Regulation Number | 866.3365 [🔎] |
TPLC Last Update: 2019-04-02 20:32:23