Medical device licence · 63220 · Class 4
COMMANDER SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 14, 2003; ended October 24, 2011. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63220
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 14, 2003
- Ended
- October 24, 2011
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMMANDER SYSTEM (RUO) HIV-1 P24 ANTIGEN (VIRAL) QUANTITATION PANEL EIA
- COMMANDER SYSTEM - HCV 2.0 EIA (DONOR SCREENING)
- COMMANDER SYSTEM -CORZYME-M (RDNA) EIA ASSAY
- COMMANDER SYSTEM ANALYZER CLASS 4
- COMMANDER SYSTEM ANTI-DELTA EIA CLASS 4
- COMMANDER SYSTEM ANTIBODY TO HUMAN T-LYMPHOTROPIC VIRUS TYPE III EIA
- COMMANDER SYSTEM AUSAB EIA
- COMMANDER SYSTEM AUSZYME ANTI-HEPATITIS B SURFACE ANTIGEN EIA
- COMMANDER SYSTEM AUSZYME MONOCLONAL EIA ASSAY (DONOR SCREENING)
- COMMANDER SYSTEM CORZYME EIA
- COMMANDER SYSTEM CORZYME-M (1236) EIA
- COMMANDER SYSTEM EIA HIVAG-1 MONOCLONAL (BLOOD SCREENING)
- COMMANDER SYSTEM EIA HIVAG-1 MONOCLONAL (DIAGNOSTIC APPLICATIONS)
- COMMANDER SYSTEM EIA HIVAG-1 MONOCLONAL ANTIBODY TO HIV TYPE 1
- COMMANDER SYSTEM HAVAB HIV-1 EIA
- COMMANDER SYSTEM HBSAG COMFIRMATORY EIA ASSAY
- COMMANDER SYSTEM HEPATITIS E (RDNA) ANTIGEN HEV EIA
- COMMANDER SYSTEM HIVAB (HIV-1/HIV-2)(RDNA) EIA (DONOR SCREENING)
- COMMANDER SYSTEM HIVAG-1 EIA MONOCLONAL BLOCKING ANTIBODY KIT (DIAG)
- COMMANDER SYSTEM HTLV-1/HTLV-11 EIA (DONOR SCREENING)
- COMMANDER SYSTEM MATRIX HCV EIA
- COMMANDER SYTEM HEPATITIS HBSAG SENTITIVITY PANEL EIA
- COMMANDER SYTEM HIVAG-1 EIA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.