ApprovalTrail

Medical device licence · 37756 · Class 2

RX DAYTONA SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed May 1, 2002. It is in Health Canada’s list of active licences.
Licence number
37756
Licence holder
Randox Laboratories Ltd.Crumlin, AT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 1, 2002
Devices covered
78

Devices on this licence

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

  • HAPTOGLOBIN (HP)
  • RX DAYTONA SYSTEM - ALBUMIN ASSAY
  • RX DAYTONA SYSTEM - ALKALINE PHOSPHATASE ASSAY
  • RX DAYTONA SYSTEM - ALKALINE PHOSPHATASE DEA ASSAY
  • RX DAYTONA SYSTEM - ALP (GDFKC)
  • RX DAYTONA SYSTEM - ALP (IFCC)
  • RX DAYTONA SYSTEM - ALT (NADH CONSUMPTION)
  • RX DAYTONA SYSTEM - ALT(ALAT/GPT)OPT ASSAY
  • RX DAYTONA SYSTEM - AMMONIA
  • RX DAYTONA SYSTEM - AMYLASE ASSAY
  • RX DAYTONA SYSTEM - ANTI-STEPTOLYSIN - O (ASO)
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN A
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN AII
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN B
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN CII
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN CIII
  • RX DAYTONA SYSTEM - APOLIPOPROTEIN E
  • RX DAYTONA SYSTEM - AST (ASAT/GOT)OPT ASSAY
  • RX DAYTONA SYSTEM - AST (GOT) OPT (NADH CONSUMPTION)
  • RX DAYTONA SYSTEM - B2MICROGLOBULIN (B2M)
  • RX DAYTONA SYSTEM - C1 SOLUTION
  • RX DAYTONA SYSTEM - CALCIUM
  • RX DAYTONA SYSTEM - CHOLESTEROL ASSAY
  • RX DAYTONA SYSTEM - CK NAC-ACTIVATED ASSAY
  • RX DAYTONA SYSTEM - CO2 (TOTAL) ASSAY
  • RX DAYTONA SYSTEM - COMPLEMENT C3
  • RX DAYTONA SYSTEM - COMPLEMENT C4
  • RX DAYTONA SYSTEM - CR BAC IOT ASSAY
  • RX DAYTONA SYSTEM - CREATININE
  • RX DAYTONA SYSTEM - CRP(C REACTIVE PROTEIN)
  • RX DAYTONA SYSTEM - CYSTATIN C (CYSC)
  • RX DAYTONA SYSTEM - DIRECT BILIRUBIN
  • RX DAYTONA SYSTEM - DIRECT HDL CHOLESTEROL ASSAY
  • RX DAYTONA SYSTEM - DURECT KDK CGIKESTERIK ASSAY
  • RX DAYTONA SYSTEM - FERRITIN
  • RX DAYTONA SYSTEM - FERRITIN (FERR) ASSAY
  • RX DAYTONA SYSTEM - FRUCTOSAMINE
  • RX DAYTONA SYSTEM - FULL RANG CRP (C-REACTIVE PROTEIN)
  • RX DAYTONA SYSTEM - GLUCOSE
  • RX DAYTONA SYSTEM - GLUCOSE (GOD/PAP) ASSAY
  • RX DAYTONA SYSTEM - GLUCOSE HEXOKINASE ASSAY
  • RX DAYTONA SYSTEM - GT ASSAY
  • RX DAYTONA SYSTEM - I.S.E. CALIBRATOR B
  • RX DAYTONA SYSTEM - I.S.E. CLEANING SOLUTION
  • RX DAYTONA SYSTEM - IGA
  • RX DAYTONA SYSTEM - IGG
  • RX DAYTONA SYSTEM - IGM (IMMUNOTURBIDIMETRIC ASSAY)
  • RX DAYTONA SYSTEM - INORGANIC PHOSPHOROUS ASSAY
  • RX DAYTONA SYSTEM - INORGANIC PHOSPHORUS (PHOS) ASSAY
  • RX DAYTONA SYSTEM - INSTRUMENT CLASS 2
  • RX DAYTONA SYSTEM - IRON ASSAY
  • RX DAYTONA SYSTEM - ISE CALIBRATOR A
  • RX DAYTONA SYSTEM - LDH (L-P) ASSAY
  • RX DAYTONA SYSTEM - LDH(P-L) ASSAY
  • RX DAYTONA SYSTEM - LIPASE
  • RX DAYTONA SYSTEM - LITHIUM ASSAY
  • RX DAYTONA SYSTEM - MAGNESIUM (MG) ASSAY
  • RX DAYTONA SYSTEM - MICROALBUMIN
  • RX DAYTONA SYSTEM - PANCREATIC AMYLASE ASSAY
  • RX DAYTONA SYSTEM - POTASSIUM (K)
  • RX DAYTONA SYSTEM - PREALBUMIN
  • RX DAYTONA SYSTEM - RHEUMATOID FACTOR
  • RX DAYTONA SYSTEM - SODIUM
  • RX DAYTONA SYSTEM - SYSTEM REAGENTS
  • RX DAYTONA SYSTEM - SYSTEM WASH SOLUTIONS
  • RX DAYTONA SYSTEM - TOTAL BILE ACIDS (TBA) ASSAY
  • RX DAYTONA SYSTEM - TOTAL BILIRUBIN
  • RX DAYTONA SYSTEM - TOTAL IRON- BINDING CAPACITY
  • RX DAYTONA SYSTEM - TOTAL PROTEIN
  • RX DAYTONA SYSTEM - TOTAL PROTEIN ASSAY
  • RX DAYTONA SYSTEM - TRANSFERRIN
  • RX DAYTONA SYSTEM - TRIGLYCERIDES
  • RX DAYTONA SYSTEM - UREA ASSAY
  • RX DAYTONA SYSTEM - UREA ASSAY
  • RX DAYTONA SYSTEM - URIC ACID
  • RX DAYTONA SYSTEM - URIC ACID ASSAY
  • RX DAYTONA SYSTEM - WASH CONCENTRATE
  • RX DAYTONA SYSTEM - Y-GT (GGT) ASSAY

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