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510(k) K102416

BD GENEOHM VANR ASSAY by Bd Diagnostics Science — Product Code NIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
August 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology

Other clearances for product code NIJ

  • K243405 — Xpert vanA (November 21, 2024)
  • K123753 — IMDX VANR FOR ABBOTT M2000 (July 17, 2013)
  • K092953 — Xpert VanA Assay (December 17, 2009)
  • K061686 — IDI-VANR ASSAY (August 30, 2006)
  • K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (May 1, 2002)