ApprovalTrail

Medical device licence · 99916 · Class 2

ALINITY I SYSTEM ASSAYS

Yes: licensed in Canada

Licence status Issued (active); first licensed October 27, 2017. It is in Health Canada’s list of active licences.
Licence number
99916
Licence holder
Abbott GmbhWiesbaden, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
October 27, 2017
Devices covered
49

Devices on this licence

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

  • ALINITY I 2ND GENERATION TESTOSTERONE CALIBRATORS
  • ALINITY I 2ND GENERATION TESTOSTERONE CONTROLS
  • ALINITY I 2ND GENERATION TESTOSTERONE REAGENT KIT
  • ALINITY I ACTIVE-B12 (HOLOTRANSCOBALAMIN) CALIBRATORS
  • ALINITY I ACTIVE-B12 (HOLOTRANSCOBALAMIN) CONTROLS
  • ALINITY I ACTIVE-B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
  • ALINITY I ANTI-CCP CALIBRATORS
  • ALINITY I ANTI-CCP CONTROLS
  • ALINITY I ANTI-CCP REAGENT KIT
  • ALINITY I C-PEPTIDE CALIBRATORS
  • ALINITY I C-PEPTIDE CONTROLS
  • ALINITY I C-PEPTIDE REAGENT KIT
  • ALINITY I DHEA-S CALIBRATORS
  • ALINITY I DHEA-S CONTROLS
  • ALINITY I DHEA-S REAGENT KIT
  • ALINITY I HAVAB IGG CALIBRATOR
  • ALINITY I HAVAB IGG CONTROLS
  • ALINITY I HAVAB IGG REAGENT KIT
  • ALINITY I HAVAB IGM CALIBRATORS
  • ALINITY I HAVAB IGM CONTROLS
  • ALINITY I HAVAB IGM REAGENT KIT
  • ALINITY I HOMOCYSTEINE CALIBRATORS
  • ALINITY I HOMOCYSTEINE CONTROLS
  • ALINITY I HOMOCYSTEINE REAGENT KIT
  • ALINITY I INSULIN CALIBRATORS
  • ALINITY I INSULIN CONTROLS
  • ALINITY I INSULIN REAGENT KIT
  • ALINITY I INTACT PTH CALIBRATORS
  • ALINITY I INTACT PTH CONTROLS
  • ALINITY I INTACT PTH REAGENT KIT
  • ALINITY I METHOTREXATE CALIBRATORS
  • ALINITY I METHOTREXATE CONTROLS
  • ALINITY I METHOTREXATE EXTENDED RANGE CONTROLS
  • ALINITY I METHOTREXATE REAGENT KIT
  • ALINITY I PEPSINOGEN I CALIBRATORS
  • ALINITY I PEPSINOGEN I CONTROLS
  • ALINITY I PEPSINOGEN I REAGENT KIT
  • ALINITY I PEPSINOGEN II CALIBRATORS
  • ALINITY I PEPSINOGEN II CONTROLS
  • ALINITY I PEPSINOGEN II REAGENT KIT
  • ALINITY I SCC CALIBRATORS
  • ALINITY I SCC CONTROLS
  • ALINITY I SCC REAGENT KIT
  • ALINITY I SHBG CALIBRATORS
  • ALINITY I SHBG CONTROLS
  • ALINITY I SHBG REAGENT KIT
  • NSE CALIBRATORS
  • NSE CONTROLS
  • NSE REAGENT KIT

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