Medical device licence · 89957 · Class 2
INDIKO PLUS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 24, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89957
- Licence holder
- Thermo Fisher Scientific Inc.Beverly, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 24, 2012
- Devices covered
- 88
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABTROL
- ALBUMIN (BCG)
- ALBUMIN MST
- ALBUMIN U CALIBRATOR
- ALBUMIN U CONTROL
- ALBUMIN U CONTROL HIGH
- ALKALINE PHOSPHATASE (IFCC) PLUS
- ALT/GPT (IFCC)
- AMYLASE (IFCC)
- APO A1/APO B CALIBRATOR
- APOLIPOPROTEIN A1
- APOLIPOPROTEIN B
- AST/GOT (IFCC)
- BICARBONATE
- BILIRUBIN DIRECT
- BILIRUBIN TOTAL (DCA)
- CALCIUM
- CHLORIDE MICRO VOLUME ELECTRODE
- CHOLESTEROL
- COMPLEMENT C3
- COMPLEMENT C4
- CREATININE (ENZYMATIC)
- CREATININE (JAFFE)
- CRP
- CRP CALIBRATION SET
- CRP CONTROL
- CRP CONTROL HIGH
- CRP HIGH SENSITIVITY
- CRP HIGH SENSITIVITY CONTROL
- D-DIMER
- D-DIMER CALIBRATION SET
- D-DIMER CONTROL
- D-DIMER CONTROL HIGH
- ECAL
- FERRITIN
- FERRITIN CALIBRATOR SET
- FERRITIN CONTROL
- FERRITIN CONTROL HIGH
- GAMMA-GT (IFCC)
- GLUCOSE (GOD-POD)
- GLUCOSE (HK)
- HBA1C
- HBA1C CALIBRATOR
- HBA1C CONTROL ABNORMAL
- HBA1C CONTROL NORMAL
- HBA1C PRETREATMENT LIQUID
- HDL-CHOLESTEROL
- HDL/LDL CALIBRATOR
- IMMUNOGLOBULIN A (IGA)
- IMMUNOGLOBULIN G (IGG)
- IMMUNOGLOBULIN M (IGM)
- INDIKO ISE CALIBRATOR 1
- INDIKO PLUS
- INDIKO PLUS WITH ISE UNIT
- IRON
- ISE CALIBRATORS
- ISE PRIME SERUM
- ISE REFERENCE
- LDH (IFCC)
- LDL-CHOLESTEROL
- LIPASE (COLORIMETRIC)
- LIPOTROL
- LIPOTROL HDL/LDL ABNORMAL
- MAGNESIUM
- NORTROL
- PHOSPHORUS
- POTASSIUM MICRO VOLUME ELECTRODE
- PYRIDOXAL PHOSPHATE
- RHEUMATOID FACTORS 2 (RF 2)
- RHEUMATOID FACTORS CONTROL
- SCAL
- SODIUM MICRO VOLUME ELECTRODE
- SPECICAL
- SPECITROL
- SPECITROL HIGH
- STFR (SOLUBLE TRANSFERRIN RECEPTOR)
- STFR CALIBRATION SET
- STFR CONTROL
- STFR CONTROL HIGH
- TOTAL PROTEIN PLUS
- TRANSFERRIN
- TRIGLYCERIDES
- U/CSF PROTEIN
- UREA
- URIC ACID (AOX)
- UTROL
- UTROL HIGH
- WASHFLUID
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 “indiko”. A notice may cover another product or only some lots: read it to see what it covers.
- Indiko System and Indiko Plus (2013-12-13)November 25, 2016 · Medical devices · Medical devices · Type III
- Indiko and Indiko Plus (2014-02-28)February 16, 2015 · 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.