Medical device licence · 101391 · Class 2
RX DAYTONA PLUS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 11, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101391
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 11, 2018
- Devices covered
- 49
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACID WASH SOLUTION (AWS)
- ALANINE AMINOTRANSFERASE (ALT)
- ALBUMIN (ALB)
- ALKALINE PHOSPHATASE (ALP)
- AMYLASE (AMY)
- ANTI-STREPTOLYSIN-O 2 (ASO 2)
- ASPARTATE AMINOTRANSFERASE (AST)
- CALCIUM (CA)
- CHOLESTEROL (CHOL)
- CK-NAC ACTIVATED (CK-NAC)
- COMPLEMENT C3 (C3)
- COMPLEMENT C4 (C4)
- CREATININE (CREA)
- DIRECT BILIRUBIN (D BIL)
- DIRECT HDL CHOLESTEROL (HDL)
- DIRECT LDL CHOLESTEROL (LDL)
- ETCHING (ETCH)
- FERRITIN
- FULL RANGE CRP (FRCRP)
- GAMMA GT (GGT)
- GLUCOSE
- GLUCOSE (GLUC-HK)
- H SOLUTION (H SOLN)
- HAEMOGLOBIN DENATURANT REAGENT (HB REAG DNT)
- IGA
- IGG
- IGM
- INORGANIC PHOSPHOROUS (PHOS)
- IRON (FE)
- ISE CLEANER (ISE CLN)
- ISE DILUENT (ISE DIL)
- L SOLUTION (L SOLN)
- LD OPT (LDH L-P)
- LD OPT (LDH P-L)
- LIPOPROTEIN A (LP(A))
- LIQUID CO2-2 (LCO2-2)
- MAGNESIUM (MG)
- POTASSIUM (K)
- REFERENCE SOLUTION (REF SOLN)
- RHEUMATOID FACTOR (RF)
- RX DAYTONA PLUS
- SALINE DILUENT (NS)
- SODIUM (NA)
- TOTAL BILIRUBIN (T BIL)
- TOTAL IRON BINDING CAPACITY 2 (TIBC 2)
- TOTAL PROTEIN 2 (TP 2)
- TRIGLYCERIDES (TRIGS)
- UREA (UREA)
- URIC ACID (UA)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.