Dna Probe, Yeast
The DNA Probe for Yeast is a nucleic acid hybridization diagnostic test used to detect and identify yeast organisms in clinical specimens, such as vaginal swabs, enabling laboratory identification of yeast-associated infections including vulvovaginal candidiasis. Classified as a Class 1 device under 21 CFR 866.2660 within the Microbiology specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
Research product code MLA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MLA
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.