510(k) DEN160001
DEN160001 is an FDA 510(k) premarket notification submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) for the device "BD MAX Vaginal Panel, BD MAX Instrument". The FDA issued a decision of De Novo Granted on October 28, 2016. The device falls under product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3975. Geneohm Sciences Canada, Inc. (Bd Diagnostics) has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 28, 2016
- Date Received
- January 11, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3975
- Review Panel
- MI
- Submission Type
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.