Definition: E. Faecalis Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For The Identification Of Enterococcus Faecalis And Other Enterococci (oe) From Blood Cultures Showing Gram-positive Cocci In Pairs And Chains.
| Device Type ID | 3521 |
| Device Name | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis |
| Physical State | A Mixture Of Fluoroscein-labeled E. Faecalis Specific PNA Probe And A Rhodamine-labeled PNA Probe Specific For Enterococcus Species Is Added To A Fixed Smear Prepared From A Positive Blood Culture Showing Gram Positive Cocci. Hybridization Is Followe |
| Technical Method | E. Faecalis PNA FISH Is A Multicolor Fluorescence In Situ Hybridization Method Using Protein Nucleic Acid Probes Hybridizing To E. Faecalis-specific Ribosomal RNA Sequences And To Ribosomal Sequences Of Other Enterococcus Species. |
| Target Area | Smears Made From Positive Blood Cultures Showing Gram Positive Cocci. |
| Regulation Description | Streptococcus Spp. 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 | 866.3740 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OAH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |