ApprovalTrail

Medical device licence · 78489 · Class 2

DIMENSION EXL SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed November 19, 2008. It is in Health Canada’s list of active licences.
Licence number
78489
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 19, 2008
Devices covered
100

Devices on this licence

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

  • DIMENSION CLINICAL CHEMISTRY SYSTEM FLEX REAGENT CARTRIDGE CRE2
  • DIMENSION EXL LOCI MODULE FLEX REAGENT CARTRIDGE VITD
  • DIMENSION EXL LOCI MODULE VITD CAL
  • DIMENSION EXL SYSTEM - ACETOMINOPHEN (ACTM) ASSAY
  • DIMENSION EXL SYSTEM - ACID PHOSPHATASE (ACP) ASSAY
  • DIMENSION EXL SYSTEM - ALANINE AMINOTRANSFERASE (ALT) ASSAY
  • DIMENSION EXL SYSTEM - ALBUMIN (ALB) ASSAY
  • DIMENSION EXL SYSTEM - ALKALINE PHOSPHATASE (ALPI) ASSAY
  • DIMENSION EXL SYSTEM - ALKALINE PHOSPHATASE CALIBRATOR (ALPI CAL)
  • DIMENSION EXL SYSTEM - AMMONIA (AMM) ASSAY
  • DIMENSION EXL SYSTEM - AMYLASE (AMY) ASSAY
  • DIMENSION EXL SYSTEM - ASPARTATE AMINOTRANSFERASE (AST) ASSAY
  • DIMENSION EXL SYSTEM - AUTOMATED HDL CHOLESTEROL (AHDL) ASSAY
  • DIMENSION EXL SYSTEM - AUTOMATED LDL (ALDL) CHOLESTEROL ASSAY
  • DIMENSION EXL SYSTEM - C-REACTIVE PROTEIN EXTENDED RANGE (RCRP) ASSAY
  • DIMENSION EXL SYSTEM - CALCIUM (CA) ASSAY
  • DIMENSION EXL SYSTEM - CARBAMAZEPINE (CRBM) ASSAY
  • DIMENSION EXL SYSTEM - CARDIO PHASE HIGH SENSITIVITY CRP (CCRP)
  • DIMENSION EXL SYSTEM - CHEMISTRY CALIBRATOR
  • DIMENSION EXL SYSTEM - CHEMISTRY II CALIBRATOR
  • DIMENSION EXL SYSTEM - CHEMISTRY III CALIBRATOR
  • DIMENSION EXL SYSTEM - CHOLESTEROL (CHOL) ASSAY
  • DIMENSION EXL SYSTEM - COMPLEMENT C3 ASSAY
  • DIMENSION EXL SYSTEM - COMPLEMENT C4 ASSAY
  • DIMENSION EXL SYSTEM - CREATINE KINASE FLEX (CKI) ASSAY
  • DIMENSION EXL SYSTEM - DIGITOXIN (DGTX) ASSAY
  • DIMENSION EXL SYSTEM - DIGOXIN (DGNA) ASSAY
  • DIMENSION EXL SYSTEM - DIMENSION EXL 200 ANALYZER
  • DIMENSION EXL SYSTEM - DIMENSION EXL ANALYSER
  • DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LOCI MODULE
  • DIMENSION EXL SYSTEM - DIRECT BILIRUBIN (DBI) ASSAY
  • DIMENSION EXL SYSTEM - DRUG CALIBRATOR
  • DIMENSION EXL SYSTEM - DRUGS OF ABUSE (DOA) CONTROLS
  • DIMENSION EXL SYSTEM - ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE (ECO2)
  • DIMENSION EXL SYSTEM - ENZYMATIC CREATININE (EZCR) ASSAY
  • DIMENSION EXL SYSTEM - ENZYME CALIBRATORS
  • DIMENSION EXL SYSTEM - ENZYME II CALIBRATOR (ENZ II CAL)
  • DIMENSION EXL SYSTEM - ENZYME VERIFIER
  • DIMENSION EXL SYSTEM - ETHYL ALCOHOL (ETOH) ASSAY
  • DIMENSION EXL SYSTEM - FERRITIN (FERR) ASSAY
  • DIMENSION EXL SYSTEM - FREE THYROXINE (FT4L) ASSAY
  • DIMENSION EXL SYSTEM - GAMMA-GLUTAMYL TRANSFERASE (GGT) ASSAY
  • DIMENSION EXL SYSTEM - GENTAMICIN (GENT) ASSAY
  • DIMENSION EXL SYSTEM - GLUCOSE (GLUC) ASSAY
  • DIMENSION EXL SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • DIMENSION EXL SYSTEM - HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
  • DIMENSION EXL SYSTEM - IMMUNOGLOBULIN A (IGA) ASSAY
  • DIMENSION EXL SYSTEM - IMMUNOGLOBULIN G (IGG) ASSAY
  • DIMENSION EXL SYSTEM - IMMUNOGLOBULIN M (IGM) ASSAY
  • DIMENSION EXL SYSTEM - IRON (IRON) ASSAY
  • DIMENSION EXL SYSTEM - LACTATE DEHYDROGENASE FLEX (LDI) ASSAY
  • DIMENSION EXL SYSTEM - LACTIC ACID (LA) ASSAY
  • DIMENSION EXL SYSTEM - LIDOCAINE (LIDO) ASSAY
  • DIMENSION EXL SYSTEM - LIPASE (LIPL) ASSAY
  • DIMENSION EXL SYSTEM - LITHIUM (LI) ASSAY
  • DIMENSION EXL SYSTEM - LOCI ANEMIA CALIBRATOR
  • DIMENSION EXL SYSTEM - LOCI FOLATE (FOLA) ASSAY
  • DIMENSION EXL SYSTEM - LOCI FREE TRIIODOTHYRONINE (FT3) ASSAY
  • DIMENSION EXL SYSTEM - LOCI MODULE UPGRADE KIT
  • DIMENSION EXL SYSTEM - LOCI THYROID CALIBRATOR
  • DIMENSION EXL SYSTEM - LOCI VITAMIN B12 (VB12) ASSAY
  • DIMENSION EXL SYSTEM - MAGNESIUM (MG) ASSAY
  • DIMENSION EXL SYSTEM - MICROALBUMIN (MALB) ASSAY
  • DIMENSION EXL SYSTEM - MULTI 2 SAMPLE DILUENT (SDIL)
  • DIMENSION EXL SYSTEM - N-ACETYLPROCAINAMIDE (NAPA) ASSAY
  • DIMENSION EXL SYSTEM - PHENOBARBITAL (PHNO) ASSAY
  • DIMENSION EXL SYSTEM - PHENYTOIN (PTN) ASSAY
  • DIMENSION EXL SYSTEM - PREALBUMIN (PALB) ASSAY
  • DIMENSION EXL SYSTEM - PROCAINAMIDE (PROC) ASSAY
  • DIMENSION EXL SYSTEM - PSEUDOCHOLINESTERASE (PCHE) ASSAY
  • DIMENSION EXL SYSTEM - QUIKLYTE INTEGRATED MULTISENSOR
  • DIMENSION EXL SYSTEM - SALICYLATE (SAL) ASSAY
  • DIMENSION EXL SYSTEM - SPECIAL PROTEIN CALIBRATOR
  • DIMENSION EXL SYSTEM - THEOPHYLINE (THEO) ASSAY
  • DIMENSION EXL SYSTEM - THYROID STIMULATING HORMONE (TSHL) ASSAY
  • DIMENSION EXL SYSTEM - THYRONINE UPTAKE (TU) ASSAY
  • DIMENSION EXL SYSTEM - THYROXINE (T4) ASSAY
  • DIMENSION EXL SYSTEM - TOBRAMYCIN (TOBR) ASSAY
  • DIMENSION EXL SYSTEM - TOTAL BILIRUBIN (TBI) ASSAY
  • DIMENSION EXL SYSTEM - TOTAL IRON BINDING CAPACITY (IBCT) ASSAY
  • DIMENSION EXL SYSTEM - TOTAL PROTEIN (TP) ASSAY
  • DIMENSION EXL SYSTEM - TRANSFERRIN (TRNF) ASSAY
  • DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) ASSAY
  • DIMENSION EXL SYSTEM - UREA NITROGEN (BUN) ASSAY
  • DIMENSION EXL SYSTEM - URIC ACID (URCA) ASSAY
  • DIMENSION EXL SYSTEM - URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) ASSAY
  • DIMENSION EXL SYSTEM - URINE BARBITURATE (BARB) SCREEN
  • DIMENSION EXL SYSTEM - URINE BENZODIAZEPINES (BENZ) SCREEN
  • DIMENSION EXL SYSTEM - URINE CANNABINOIDS (THC) SCREEN
  • DIMENSION EXL SYSTEM - URINE COCAINE (COC) METABOLITE SCREEN
  • DIMENSION EXL SYSTEM - URINE ECSTASY (EXTC) SCREEN
  • DIMENSION EXL SYSTEM - URINE METHADONE (METH) SCREEN
  • DIMENSION EXL SYSTEM - URINE OPIATES (OPI) SCREEN
  • DIMENSION EXL SYSTEM - URINE PHENCYCLIDINE (PCP) SCREEN
  • DIMENSION EXL SYSTEM - URINE/CEREBROSPINAL FLUID PROTEIN (UCFP) ASSAY
  • DIMENSION EXL SYSTEM - VALPROIC ACID (VALP) ASSAY
  • DIMENSION EXL SYSTEM - VANCOMYCIN (VANC) ASSAY
  • DIMENSION HEMOGLOBIN A1C
  • DIMENTION CLINICAL CHEMISTRY SYSTEM FLEX REAGENT CARTRIDGE PHOS
  • LIPASE CALIBRATOR

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