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510(k) K123753

IMDX VANR FOR ABBOTT M2000 by Intelligent Medical Devices, Inc. — Product Code NIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2013
Date Received
December 6, 2012
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 by Intelligent Medical Devices, Inc.

  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K132235 — IMDX C.DIFFICILE FOR ABBOTT M2000 (October 11, 2013)
  • K131584 — IMDX FLU A/B AND RSV FOR ABBOTT M2000 (August 21, 2013)

Other clearances for product code NIJ

  • K243405 — Xpert vanA (November 21, 2024)
  • K102416 — BD GENEOHM VANR ASSAY (October 20, 2011)
  • K092953 — Xpert VanA Assay (December 17, 2009)
  • K061686 — IDI-VANR ASSAY (August 30, 2006)
  • K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (May 1, 2002)