Dna Probe, Gardnerella Vaginalis
The DNA Probe for Gardnerella vaginalis is a nucleic acid hybridization diagnostic test used to detect Gardnerella vaginalis DNA in vaginal specimens, assisting in the laboratory diagnosis of bacterial vaginosis and characterizing the vaginal microbiome. Classified as a Class 1 device under 21 CFR 866.2660 in 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.
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Basic Information
- Product Code
- MJM
- 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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.