ApprovalTrail

Medical device licence · 7829 · Class 2

ARRAY SYSTEMS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 12, 1999; ended September 19, 2012. It is in Health Canada’s archive of licences no longer in force.
Licence number
7829
Licence holder
Beckman Coulter, Inc.San Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 12, 1999
Ended
September 19, 2012
Devices covered
37

Devices on this licence

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

  • ARRAY SYSTEM 360 ANALYZER - CLASS 2
  • ARRAY SYSTEM ALPHA 2 MACROGLOBULIN REAGENT
  • ARRAY SYSTEM ALPHA-1-MICROGLOBULIN (A1M) REAGENT
  • ARRAY SYSTEM ANTITHROMBIN III (AT3) REAGENT KIT
  • ARRAY SYSTEM APA (APOLIPOPROTEIN A-1 REAGENT)
  • ARRAY SYSTEM APB (APOLIPOPROTEIN B REAGENT)
  • ARRAY SYSTEM ASO REAGENT (ANTI-STREPTOLYSIN O REAGENT)
  • ARRAY SYSTEM BETA-2-MICROGLOBULIN (B2M) REAGENT
  • ARRAY SYSTEM CARBAMAZEPINE REAGENTS
  • ARRAY SYSTEM GENTAMICIN REAGENT
  • ARRAY SYSTEM ICS ALBUMIN (ALB) REAGENT TEST KIT
  • ARRAY SYSTEM ICS ALPHA 1 -ANTIRYPSIN (ATT)REAGENT TEST KIT
  • ARRAY SYSTEM ICS ALPHA 1-ACID GLYCOPROTEIN (AAG) REAGENT KIT
  • ARRAY SYSTEM ICS C REACTIVE PROTEIN (CRP) REAGENT TEST KIT
  • ARRAY SYSTEM ICS CERULO PLASMIN (CER) REAGENT TEST KIT
  • ARRAY SYSTEM ICS COMPLEMENT C3 REAGENT TEST KIT
  • ARRAY SYSTEM ICS COMPLEMENT C4 REAGENT TEST KIT
  • ARRAY SYSTEM ICS HAPTOGLOBIN (HPT) REGENT TEST KIT
  • ARRAY SYSTEM ICS IMMUNO GLOBULIN A (IGA) REAGENT TEST KIT
  • ARRAY SYSTEM ICS IMMUNO GLOBULIN A (IGA) REAGENT TEST KIT
  • ARRAY SYSTEM ICS PHENYTOIN REAGENT KIT
  • ARRAY SYSTEM IGG-IMMUNOGLOBULIN G REAGENT
  • ARRAY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT
  • ARRAY SYSTEM LAMBDA LIGHT CHAIN (LAM) REAGENT
  • ARRAY SYSTEM LPA LIPOPROTEIN (A) REAGENT
  • ARRAY SYSTEM MICROALBUMIN (MA) REAGENT
  • ARRAY SYSTEM PAB-PREALBUMIN REAGENT
  • ARRAY SYSTEM PFB-PROPERDIN FACTOR B REAGENT
  • ARRAY SYSTEM PHENOBARBITAL REAGENTS
  • ARRAY SYSTEM PRI (PRIMIDONE) REAGENT
  • ARRAY SYSTEM QUINIDINE REAGENT
  • ARRAY SYSTEM RFMPE RHEUMATOID FACTOR MICROPARTICULATE ENHANCED REAGENT
  • ARRAY SYSTEM THEOPHYLLINE REAGENTS
  • ARRAY SYSTEM TOBRAMYCIN REAGENT
  • ARRAY SYSTEM TRF-TRANSFERRIN REAGENT
  • ARRAY SYSTEM VPA (VALPORIC ACID REAGENT)
  • ARRAY SYSTEMS - RHEUMATOID FACTOR (RHF) ASSAY

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