Definition: The S. Aureus Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For Presumptive Identification Of Staphylococcus Aureus From Blood Cultures With Gram-positive Cocci In Clusters (gpcc). This Device Is Not Exempt Per 21 Cfr Part 866.9
| Device Type ID | 3519 |
| Device Name | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus |
| Physical State | Kit Box Containing 1.5 Ml Fixation Solution, S. Aureus-specific PNA Probe In Hybridization Solution, Wash Solution And Mounting Medium. One-well Microscope Slides, Fluorescent Microscope Equipped With A Dual Band Filter, And Control Slides Are Requir |
| Technical Method | Fluorescent In Situ Hybridization Using Protein Nucleic Acid (PNA) Probes. |
| Target Area | Systemic Blood Culture |
| Regulation Description | Staphylococcus Aureus Serological Reagents. |
| 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) Exempt |
| CFR Regulation Number | 866.3700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NXX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |