ApprovalTrail

Medical device licence · 76662 · Class 3

DIMENSION VISTA SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed March 28, 2008. It is in Health Canada’s list of active licences.
Licence number
76662
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 28, 2008
Devices covered
24

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CTNI SAMPLE DILUENT
  • DIMENSION VISTA SYSTEM - ALPHA-FETOPROTEIN (AFP)
  • DIMENSION VISTA SYSTEM - CA125 FLEX REAGENT CARTRIDGE
  • DIMENSION VISTA SYSTEM - CA15-3 FLEX REAGENT CARTRIDGE
  • DIMENSION VISTA SYSTEM - CA19-9 FLEX REAGENT CARTRIDGE
  • DIMENSION VISTA SYSTEM - CARCINOEMBRYONIC ANTIGEN (CEA)
  • DIMENSION VISTA SYSTEM - CARDIAC TROPONIN I (CTNI)
  • DIMENSION VISTA SYSTEM - CREATINE KINASE MB (MBI) ASSAY
  • DIMENSION VISTA SYSTEM - CTNI CALIBRATOR
  • DIMENSION VISTA SYSTEM - DIMENSION VISTA 1000T AND 3000T TWINNING KIT
  • DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER
  • DIMENSION VISTA SYSTEM - DIMENSION VISTA 500 ANALYZER
  • DIMENSION VISTA SYSTEM - FREE PROSTATE SPECIFIC ANTIGEN (FPSA) ASSAY
  • DIMENSION VISTA SYSTEM - HIGH SENSITIVITY TROPONIN I (TNIH)
  • DIMENSION VISTA SYSTEM - HIGH SENSITIVITY TROPONIN I CALIBRATOR (TNIH CAL)
  • DIMENSION VISTA SYSTEM - LOCI 6 CALIBRATOR
  • DIMENSION VISTA SYSTEM - LOCI 7 CALIBRATOR
  • DIMENSION VISTA SYSTEM - MASS CREATINE KINASE MB ISOENZYME (MMB)
  • DIMENSION VISTA SYSTEM - MMB CALIBRATOR
  • DIMENSION VISTA SYSTEM - MYO CALIBRATOR
  • DIMENSION VISTA SYSTEM - MYOGLOBIN (MYO)
  • DIMENSION VISTA SYSTEM - N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP)
  • DIMENSION VISTA SYSTEM - PBNP ASSAY
  • DIMENSION VISTA SYSTEM - TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.