Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
The FISH (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, RNA, Yeast (product code NZS) is a qualitative nucleic acid hybridization assay used for the identification of Candida albicans from blood cultures with yeast, aiding in the rapid diagnosis of candidemia. It is classified as FDA Class 1, regulated under 21 CFR 866.2660 within the Microbiology specialty, and is exempt from 510(k) requirements. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZS
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
Definition
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093024 | YEAST TRAFFIC LIGHT PNA FISH | Jul 15, 2010 | Substantially Equivalent | Advandx, Inc. |
| K092784 | C. ALBICANS/C. GLABRATA PNA FISH | Mar 12, 2010 | Substantially Equivalent | Advandx, Inc. |
| K092655 | C. ALBICANS PNA FISH | Jan 19, 2010 | Substantially Equivalent | Advandx, Inc. |