Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
The FISH (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (product code OAH) is a qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and other enterococci from blood cultures showing gram-positive cocci in pairs and chains. It is classified as FDA Class 1, regulated under 21 CFR 866.3740 within the Microbiology specialty, and is not GMP-exempt. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAH
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121991 | ENTEROCOCCUS QUICKFISH BC | Jan 07, 2013 | Substantially Equivalent | Advandx, Inc. |
| K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | Jul 24, 2009 | Substantially Equivalent | Advandx, Inc. |
| K082612 | GBS PNA FISH | May 05, 2009 | Substantially Equivalent | Advandx, Inc. |
| K063127 | ENTEROCOCCUS FAECALIS PNA FISH | Dec 22, 2006 | Substantially Equivalent | Advandx, Inc. |