ApprovalTrail

Medical device licence · 30615 · Class 2

DIMENSION XPAND SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 5, 2001. It is in Health Canada’s list of active licences.
Licence number
30615
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
July 5, 2001
Devices covered
90

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 HEMOGLOBIN A1C
  • DIMENSION XPAND PLUS BASIC ANALYZER - CLASS 2
  • DIMENSION XPAND SYSTEM - ACETOMINOPHEN (ACTM) ASSAY
  • DIMENSION XPAND SYSTEM - ACID PHOSPHATASE (ACP) ASSAY
  • DIMENSION XPAND SYSTEM - ALANINE AMINOTRANSFERASE (ALT) ASSAY
  • DIMENSION XPAND SYSTEM - ALBUMIN (ALB) ASSAY
  • DIMENSION XPAND SYSTEM - ALKALINE PHOSPHATASE (ALPI) ASSAY
  • DIMENSION XPAND SYSTEM - ALKALINE PHOSPHATASE CALIBRATOR (ALPICAL)
  • DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY
  • DIMENSION XPAND SYSTEM - AMYLASE (AMY) ASSAY
  • DIMENSION XPAND SYSTEM - ASPARTATE AMINOTRANSFERASE (AST) ASSAY
  • DIMENSION XPAND SYSTEM - AUTOMATED HDL CHOLESTEROL (AHDL) ASSAY
  • DIMENSION XPAND SYSTEM - AUTOMATED LDL (ALDL) CHOLESTEROL ASSAY
  • DIMENSION XPAND SYSTEM - C-REACTIVE PROTEIN EXTENDED RANGE (RCRP) ASSAY
  • DIMENSION XPAND SYSTEM - CALCIUM (CA) ASSAY
  • DIMENSION XPAND SYSTEM - CARBAMAZEPINE (CRBM) ASSAY
  • DIMENSION XPAND SYSTEM - CARDIO PHASE HIGH SENSITIVITY CRP (CCRP)
  • DIMENSION XPAND SYSTEM - CHEMISTRY CALIBRATOR
  • DIMENSION XPAND SYSTEM - CHEMISTRY III CALIBRATOR
  • DIMENSION XPAND SYSTEM - CHOLESTEROL (CHOL) ASSAY
  • DIMENSION XPAND SYSTEM - COMPLEMENT C3 ASSAY
  • DIMENSION XPAND SYSTEM - COMPLEMENT C4 ASSAY
  • DIMENSION XPAND SYSTEM - CREATINE KINASE FLEX (CKI) ASSAY
  • DIMENSION XPAND SYSTEM - DIGITOXIN (DGTX) ASSAY
  • DIMENSION XPAND SYSTEM - DIGOXIN (DGNA) ASSAY
  • DIMENSION XPAND SYSTEM - DIMENSION XPAND HM ANALYZER - CLASS 2
  • DIMENSION XPAND SYSTEM - DIRECT BILIRUBIN (DBI) ASSAY
  • DIMENSION XPAND SYSTEM - DRUG CALIBRATOR
  • DIMENSION XPAND SYSTEM - DRUGS OF ABUSE (DOA) CONTROLS
  • DIMENSION XPAND SYSTEM - ENZYMATIC CARBONATE FLEX REAGENT
  • DIMENSION XPAND SYSTEM - ENZYMATIC CREATININE (EZCR) ASSAY
  • DIMENSION XPAND SYSTEM - ENZYME CALIBRATORS
  • DIMENSION XPAND SYSTEM - ENZYME II CALIBRATOR (ENZ II CAL)
  • DIMENSION XPAND SYSTEM - ENZYME VERIFIER
  • DIMENSION XPAND SYSTEM - ETHYL ALCOHOL (ETOH) ASSAY
  • DIMENSION XPAND SYSTEM - FERRITIN (FERR) ASSAY
  • DIMENSION XPAND SYSTEM - FREE THYROXINE (FT4) ASSAY
  • DIMENSION XPAND SYSTEM - GAMMA-GLUTAMYL TRANSFERASE (GGT) ASSAY
  • DIMENSION XPAND SYSTEM - GENTAMICIN (GENT) ASSAY
  • DIMENSION XPAND SYSTEM - GLUCOSE (GLUC) ASSAY
  • DIMENSION XPAND SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • DIMENSION XPAND SYSTEM - HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
  • DIMENSION XPAND SYSTEM - HUMAN CHORIONIC GONADOTROPIN FLEX (LHCG)
  • DIMENSION XPAND SYSTEM - IMMUNOGLOBULIN A (IGA) ASSAY
  • DIMENSION XPAND SYSTEM - IMMUNOGLOBULIN G (IGG) ASSAY
  • DIMENSION XPAND SYSTEM - IMMUNOGLOBULIN M (IGM) ASSAY
  • DIMENSION XPAND SYSTEM - IRON (IRON) ASSAY
  • DIMENSION XPAND SYSTEM - LACTATE DEHYDROGENASE FLEX (LDI) ASSAY
  • DIMENSION XPAND SYSTEM - LACTIC ACID (LA) ASSAY
  • DIMENSION XPAND SYSTEM - LIDOCAINE (LIDO) ASSAY
  • DIMENSION XPAND SYSTEM - LIPASE FLEX (LIPL) ASSAY
  • DIMENSION XPAND SYSTEM - LITHIUM (LI) ASSAY
  • DIMENSION XPAND SYSTEM - MAGNESIUM (MG) ASSAY
  • DIMENSION XPAND SYSTEM - MICROALBUMIN (MALB) ASSAY
  • DIMENSION XPAND SYSTEM - N-ACETYLPROCAINAMIDE (NAPA) ASSAY
  • DIMENSION XPAND SYSTEM - PHENOBARBITAL (PHNO) ASSAY
  • DIMENSION XPAND SYSTEM - PHENYTOIN (PTN) ASSAY
  • DIMENSION XPAND SYSTEM - PROCAINAMIDE (PROC) ASSAY
  • DIMENSION XPAND SYSTEM - PSEUDOCHOLINESTERASE (PCHE) ASSAY
  • DIMENSION XPAND SYSTEM - QUIKLYTE INTEGRATED MULTISENSOR
  • DIMENSION XPAND SYSTEM - SALICYLATE (SAL) ASSAY
  • DIMENSION XPAND SYSTEM - SPECIAL PROTEIN CALIBRATOR
  • DIMENSION XPAND SYSTEM - THEOPHYLINE (THEO) ASSAY
  • DIMENSION XPAND SYSTEM - THYROID STIMULATING HORMONE (TSH) ASSAY
  • DIMENSION XPAND SYSTEM - THYRONINE UPTAKE (TU) ASSAY
  • DIMENSION XPAND SYSTEM - THYROXINE (T4) ASSAY
  • DIMENSION XPAND SYSTEM - TOBRAMYCIN (TOBR) ASSAY
  • DIMENSION XPAND SYSTEM - TOTAL BILIRUBIN (TBI) ASSAY
  • DIMENSION XPAND SYSTEM - TOTAL IRON BINDING CAPACITY (IBCT) ASSAY
  • DIMENSION XPAND SYSTEM - TOTAL PROTEIN (TP) ASSAY
  • DIMENSION XPAND SYSTEM - TRANSFERRIN (TRNF) ASSAY
  • DIMENSION XPAND SYSTEM - TRIGLYCERIDES (TGL) ASSAY
  • DIMENSION XPAND SYSTEM - UREA NITROGEN (BUN) ASSAY
  • DIMENSION XPAND SYSTEM - URIC ACID (URCA) ASSAY
  • DIMENSION XPAND SYSTEM - URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) ASSAY
  • DIMENSION XPAND SYSTEM - URINE BARBITURATE (BARB) SCREEN
  • DIMENSION XPAND SYSTEM - URINE BENZODIAZEPINES (BENZ) SCREEN
  • DIMENSION XPAND SYSTEM - URINE CANNABINOIDS (THC) SCREEN
  • DIMENSION XPAND SYSTEM - URINE COCAINE (COC) METABOLITE SCREEN
  • DIMENSION XPAND SYSTEM - URINE ECSTASY (EXTC) SCREEN
  • DIMENSION XPAND SYSTEM - URINE METHADONE (METH) SCREEN
  • DIMENSION XPAND SYSTEM - URINE OPIATES (OPI) SCREEN
  • DIMENSION XPAND SYSTEM - URINE PHENCYCLIDINE (PCP) SCREEN
  • DIMENSION XPAND SYSTEM - URINE/CEREBROSPINAL FLUID PROTEIN (UCFP) ASSAY
  • DIMENSION XPAND SYSTEM - VALPROIC ACID (VALP) ASSAY
  • DIMENSION XPAND SYSTEM - VANCOMYCIN (VANC) ASSAY
  • DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER - CLASS 2
  • 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.