Test, Vaginal, Bacterial Sialidase
A Vaginal Bacterial Sialidase Test is an in vitro diagnostic device that detects sialidase enzymatic activity in vaginal swab specimens as a marker for bacterial vaginosis and associated polymicrobial infection, supporting rapid point-of-care diagnosis. It is FDA Class 1, subject only to general controls, with product code MXB under 21 CFR 866.2660 in the Microbiology specialty. No premarket notification is required. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MXB
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- CH
- 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 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.