Medical device licence · 22449 · Class 4
ARCHITECT "I" SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 22449
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 28, 2000
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT "I" SYSTEM - ANTI-HBC II (DONOR SCREENING & CADAVERIC TESTING) REAGENT KIT
- ARCHITECT "I" SYSTEM - ANTI-HBE ASSAY
- ARCHITECT "I" SYSTEM - ANTI-HCV DONOR SCREENING AND CADAVERIC TESTING
- ARCHITECT "I" SYSTEM - HBEAG ASSAY
- ARCHITECT "I" SYSTEM - HCV AG ASSAY
- ARCHITECT "I" SYSTEM - HIV AG/AB COMBO ASSAY (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT "I" SYSTEM - RHTLV-I/II CALIBRATOR
- ARCHITECT "I" SYSTEM - RHTLV-I/II REAGENT KIT (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT "I" SYSTEM - RHTLV-I/II REAGENT KIT CONTROLS
- ARCHITECT ANTI-HBC IGM CALIBRATORS
- ARCHITECT ANTI-HBC IGM CONTROLS
- ARCHITECT ANTI-HBC IGM REAGENT KIT
- ARCHITECT CHAGAS CALIBRATORS
- ARCHITECT CHAGAS CONTROLS
- ARCHITECT CHAGAS REAGENT KIT (DONOR SCREENING/CADAVERIC)
- ARCHITECT HBEAG QUANTITATIVE CALIBRATORS
- ARCHITECT HBEAG QUANTITATIVE CONTROLS
- ARCHITECT HBEAG REAGENT KIT
- ARCHITECT HCV AG REAGENT KIT
- ARCHITECT SYPHILIS TP CALIBRATOR (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT SYPHILIS TP CONTROL (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT SYPHILIS TP REAGENT (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT SYPHILIS TP REAGENT KIT (DONOR SCREENING AND CADAVERIC TESTING)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.