NZS — Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast Class I
FDA product code NZS covers "Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NZS
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.