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510(k) DEN160001

BD MAX Vaginal Panel, BD MAX Instrument by Geneohm Sciences Canada, Inc. (Bd Diagnostics) — Product Code PQA

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.

Other clearances by Geneohm Sciences Canada, Inc. (Bd Diagnostics)

  • K191957 — BD MAX Vaginal Panel (October 21, 2019)
  • K132822 — BD MAX STAPHSR ASSAY, INSTRUMENT (November 26, 2013)
  • K130470 — BD MAX CDIFF ASSAY, BD MAX INSTRUMENT (April 2, 2013)

Other clearances for product code PQA

  • K243725 — BD Vaginal Panel (December 19, 2024)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K223653 — BD Vaginal Panel (March 6, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)
  • K201017 — BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (October 18, 2021)
  • K191957 — BD MAX Vaginal Panel (October 21, 2019)
  • K190452 — Aptima BV Assay (May 23, 2019)
  • K190472 — Aptima CV/TV Assay (May 16, 2019)