Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
OAH is the FDA product code for Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis, a class I device type, regulated under 21 CFR 866.3740. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- OAH
- Device name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
- 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.
- Regulation
- 21 CFR 866.3740
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 1
Clearances, product code OAH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 2 |
| 2013 | 1 |
Applicants with the most clearances
Product code OAH| Applicant | Clearances |
|---|---|
| Advandx, Inc. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OAH.
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