Definition: Indicated As A Qualitative Nucleic Acid Hybridization Assay Intended For Identification Of Candida Albicans From Blood Cultures With Yeast.
| Device Type ID | 3520 |
| Device Name | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast |
| Physical State | Kit Contains 3 Ml Bottle Fixation Solution, 1.5 Ml Bottle Fluorescein Labeled PNA Probe In Hybridization Solution, 50 Ml Concentrated Wash Solution. One Well, Teflon Coated Microscope Slides Available From Manufacturer. |
| Technical Method | PNA Probe Is Added To A Fixed Smear Prepared From Liquid Blood Culture Media With Yeast. Hybridization Is Performed During A 90 Minute Incubation At 55 Degrees C In An Incubator Or Slide Warmer. The Slide Is Examined By Fluorescent Microscopy Within |
| Target Area | Systemic Blood Cultures |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NZS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |