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 It is in Health Canada’s archive of licences no longer in force.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.