NZS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- FDA definition
- Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| YEAST TRAFFIC LIGHT PNA FISH (K093024) | Advandx, Inc. | 2010-07-15 |
| C. ALBICANS/C. GLABRATA PNA FISH (K092784) | Advandx, Inc. | 2010-03-12 |
| C. ALBICANS PNA FISH (K092655) | Advandx, Inc. | 2010-01-19 |
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