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510(k) K061686

IDI-VANR ASSAY by Geneohm Sciences Canada, Inc. — Product Code NIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2006
Date Received
June 15, 2006
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

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  • K102416 — BD GENEOHM VANR ASSAY (October 20, 2011)
  • K092953 — Xpert VanA Assay (December 17, 2009)
  • K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (May 1, 2002)