Medical device licence · 95482 · Class 2
OPTILITE ANALYSER
Yes: licensed in Canada
Licence status Issued (active); first licensed July 22, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95482
- Licence holder
- The Binding Site Group LimitedBirmingham, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 22, 2015
- Devices covered
- 123
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-TETANUS TOXOID OPTILITE KIT
- OPTILITE A1-ACID GLYCOPROTEIN KIT
- OPTILITE ALBUMIN CONTROL PACK
- OPTILITE ALBUMIN KIT
- OPTILITE ALPHA-1-ANTITRYPSIN CONTROL PACK
- OPTILITE ALPHA-1-ANTITRYPSIN KIT
- OPTILITE ALPHA-1-MICROGLOBULIN URINE CONTROL PACK
- OPTILITE ALPHA-1-MICROGLOBULIN URINE KIT
- OPTILITE ALPHA-2-MACROGLOBULIN CONTROL PACK
- OPTILITE ALPHA-2-MACROGLOBULIN KIT
- OPTILITE ALPHA1-ACID GLYCOPROTEIN CONTROL PACK
- OPTILITE ANALYSER
- OPTILITE ANTI-STREPTOLYSIN O CONTROL PACK
- OPTILITE ANTI-STREPTOLYSIN O KIT
- OPTILITE ANTI-TETANUS TOXOID IMMUNOGLOBULIN CONTROL PACK
- OPTILITE APOLIPOPROTEIN A-1 CALIBRATOR
- OPTILITE APOLIPOPROTEIN A-1 CONTROLS
- OPTILITE APOLIPOPROTEIN A-1 REAGENT
- OPTILITE APOLIPOPROTEIN B CALIBRATOR
- OPTILITE APOLIPOPROTEIN B CONTROLS
- OPTILITE APOLIPOPROTEIN B REAGENT
- OPTILITE BETA-2 MICROGLOBULIN CONTROL PACK
- OPTILITE BETA-2 MICROGLOBULIN KIT
- OPTILITE BETA-2 MICROGLOBULIN URINE CONTROL PACK
- OPTILITE BETA-2 MICROGLOBULIN URINE KIT
- OPTILITE C-REACTIVE PROTEIN CALIBRATOR
- OPTILITE C-REACTIVE PROTEIN CONTROLS
- OPTILITE C-REACTIVE PROTEIN REAGENT
- OPTILITE C1 INACTIVATOR CONTROL PACK
- OPTILITE C1 INACTIVATOR KIT
- OPTILITE C1Q CONTROL PACK
- OPTILITE C1Q KIT
- OPTILITE C2 CONTROL PACK
- OPTILITE C2 KIT
- OPTILITE C3C CONTROL PACK
- OPTILITE C3C KIT
- OPTILITE C4 CONTROL PACK
- OPTILITE C4 KIT
- OPTILITE CAERULOPLASMIN CONTROL PACK
- OPTILITE CAERULOPLASMIN KIT
- OPTILITE CH50 CALIBRATOR
- OPTILITE CH50 CONTROLS
- OPTILITE CH50 REAGENT
- OPTILITE CYSTATIN C CONTROL PACK
- OPTILITE CYSTATIN C KIT
- OPTILITE DILUENT
- OPTILITE FREELITE KAPPA FREE BULK KIT
- OPTILITE FREELITE KAPPA FREE CONTROL PACK
- OPTILITE FREELITE KAPPA FREE KIT
- OPTILITE FREELITE LAMBDA FREE BULK KIT
- OPTILITE FREELITE LAMBDA FREE CONTROL PACK
- OPTILITE FREELITE LAMBDA FREE KIT
- OPTILITE FREELITE MX KAPPA FREE CONTROL PACK
- OPTILITE FREELITE MX KAPPA FREE KIT
- OPTILITE FREELITE MX KAPPA FREE KIT
- OPTILITE FREELITE MX LAMBDA FREE CONTROL PACK
- OPTILITE FREELITE MX LAMBDA FREE KIT
- OPTILITE FREELITE MX LAMBDA FREE KIT
- OPTILITE HAPTOGLOBIN CONTROL PACK
- OPTILITE HAPTOGLOBIN KIT
- OPTILITE HEVYLITE IGA KAPPA CONTROL PACK
- OPTILITE HEVYLITE IGA KAPPA KIT
- OPTILITE HEVYLITE IGA LAMBDA CONTROL PACK
- OPTILITE HEVYLITE IGA LAMBDA KIT
- OPTILITE HEVYLITE IGG KAPPA CONTROL PACK
- OPTILITE HEVYLITE IGG KAPPA KIT
- OPTILITE HEVYLITE IGG LAMBDA CONTROL PACK
- OPTILITE HEVYLITE IGG LAMBDA KIT
- OPTILITE HEVYLITE IGM KAPPA CONTROL PACK
- OPTILITE HEVYLITE IGM KAPPA KIT
- OPTILITE HEVYLITE IGM LAMBDA CONTROL PACK
- OPTILITE HEVYLITE IGM LAMBDA KIT
- OPTILITE HIGH SENSITIVITY C-REACTIVE PROTEIN CONTROL PACK
- OPTILITE HIGH SENSITIVITY C-REACTIVE PROTEIN KIT
- OPTILITE IGA CONTROL PACK
- OPTILITE IGA CSF CONTROL PACK
- OPTILITE IGA CSF KIT
- OPTILITE IGA KIT
- OPTILITE IGA1 CONTROL PACK
- OPTILITE IGA1 KIT
- OPTILITE IGA2 CONTROL PACK
- OPTILITE IGA2 KIT
- OPTILITE IGD CONTROL PACK
- OPTILITE IGD KIT
- OPTILITE IGE CALIBRATOR
- OPTILITE IGE CONTROLS
- OPTILITE IGE REAGENT
- OPTILITE IGG CONTROL PACK
- OPTILITE IGG KIT
- OPTILITE IGG1 CONTROL PACK
- OPTILITE IGG1 KIT
- OPTILITE IGG2 CONTROL PACK
- OPTILITE IGG2 KIT
- OPTILITE IGG3 CONTROL PACK
- OPTILITE IGG3 KIT
- OPTILITE IGG4 CONTROL PACK
- OPTILITE IGG4 KIT
- OPTILITE IGM CONTROL PACK
- OPTILITE IGM CSF CONTROL PACK
- OPTILITE IGM CSF KIT
- OPTILITE IGM KIT
- OPTILITE LIPOPROTEIN (A) CALIBRATOR
- OPTILITE LIPOPROTEIN (A) CONTROLS
- OPTILITE LIPOPROTEIN (A) REAGENT
- OPTILITE LOW LEVEL ALBUMIN CONTROL PACK
- OPTILITE LOW LEVEL ALBUMIN KIT
- OPTILITE LOW LEVEL IGG CONTROL PACK
- OPTILITE LOW LEVEL IGG KIT
- OPTILITE LOW LEVEL TOTAL PROTEIN CALIBRATOR
- OPTILITE LOW LEVEL TOTAL PROTEIN CONTROLS
- OPTILITE LOW LEVEL TOTAL PROTEIN REAGENT
- OPTILITE PREALBUMIN CONTROL PACK
- OPTILITE PREALBUMIN KIT
- OPTILITE RHEUMATOID FACTOR CONTROL PACK
- OPTILITE RHEUMATOID FACTOR KIT
- OPTILITE SPECIAL WASH 1
- OPTILITE TOTAL PROTEIN CALIBRATOR
- OPTILITE TOTAL PROTEIN CONTROLS
- OPTILITE TOTAL PROTEIN REAGENT
- OPTILITE TRANSFERRIN CONTROL PACK
- OPTILITE TRANSFERRIN KIT
- OPTILITE TRANSFERRIN URINE CONTROL PACK
- OPTILITE TRANSFERRIN URINE KIT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “optilite”. A notice may cover another product or only some lots: read it to see what it covers.
- Optilite Analyser (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type III
- Optilite Low Level Albumin Kit (2019-12-19)January 10, 2020 · Medical devices · Medical devices · Type III
- Optilite IgM Kit (2019-07-19)August 16, 2019 · Medical devices · Medical devices · Type III
- Optilite Beta-2-microglobulin Urine Kit (2018-03-09)April 3, 2018 · Medical devices · Medical devices · Type II
- Optilite Holmium Fiber Assembly and Lser Fibers (2017-06-13)July 7, 2017 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.