OAH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Medical specialty
- Microbiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENTEROCOCCUS QUICKFISH BC (K121991) | Advandx, Inc. | 2013-01-07 |
| AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074) | Advandx, Inc. | 2009-07-24 |
| GBS PNA FISH (K082612) | Advandx, Inc. | 2009-05-05 |
| ENTEROCOCCUS FAECALIS PNA FISH (K063127) | Advandx, Inc. | 2006-12-22 |
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Every clearance here is in the API, with alerts when new ones post.