← FDA Medical Device Classifications
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
NZS · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2660
Classification
- FDA Product Code
NZS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 866.2660
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown