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) |
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 |