Medical device licence · 64284 · Class 2
ARCHITECT I SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 5, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64284
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 5, 2004
- Devices covered
- 52
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT B-R-A-H-M-S PCT CALIBRATORS
- ARCHITECT B-R-A-H-M-S PCT CONTROLS
- ARCHITECT B-R-A-H-M-S PCT REAGENT KIT
- ARCHITECT C-PEPTIDE CALIBRATORS
- ARCHITECT C-PEPTIDE CONTROLS
- ARCHITECT C-PEPTIDE REAGENT KIT
- ARCHITECT HAVAB-IGM CALIBRATOR
- ARCHITECT HAVAB-IGM CONTROLS
- ARCHITECT HAVAB-IGM REAGENT KIT
- ARCHITECT HOMOCYSTEINE REAGENT KIT
- ARCHITECT I - 2ND GENERATION TESTOSTERONE CALIBRATOR
- ARCHITECT I - 2ND GENERATION TESTOSTERONE CONTROL
- ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT
- ARCHITECT I SYSTEM - ACTIVE B12 (HOLOTC) CALIBRATOR
- ARCHITECT I SYSTEM - ACTIVE B12 (HOLOTC) CONTROL
- ARCHITECT I SYSTEM - ACTIVE B12 (HOLOTC) REAGENT
- ARCHITECT I SYSTEM - ANTI-CCP ASSAY
- ARCHITECT I SYSTEM - DHEA-S ASSAY
- ARCHITECT I SYSTEM - HOMOCYSTEINE ASSAY
- ARCHITECT I SYSTEM - IGENTAMICIN CALIBRATORS
- ARCHITECT I SYSTEM - IGENTAMICIN REAGENT KIT
- ARCHITECT I SYSTEM - PEPSINOGEN I CALIBRATORS
- ARCHITECT I SYSTEM - PEPSINOGEN I CONTROLS
- ARCHITECT I SYSTEM - PEPSINOGEN I REAGENT KIT
- ARCHITECT I SYSTEM - PEPSINOGEN II CALIBRATORS
- ARCHITECT I SYSTEM - PEPSINOGEN II CONTROLS
- ARCHITECT I SYSTEM - PEPSINOGEN II REAGENT KIT
- ARCHITECT I SYSTEM - SHBG ASSAY
- ARCHITECT I SYSTEM - VANCOMYCIN ASSAY
- ARCHITECT INSULIN CALIBRATORS
- ARCHITECT INSULIN CONTROLS
- ARCHITECT INSULIN REAGENT KIT
- ARCHITECT INTACT PTH CALIBRATORS
- ARCHITECT METHOTREXATE CALIBRATORS
- ARCHITECT METHOTREXATE CONTROLS
- ARCHITECT METHOTREXATE EXTENDED RANGE CONTROLS
- ARCHITECT METHOTREXATE REAGENT KIT
- ARCHITECT MICROALBUMIN CALIBRATORS
- ARCHITECT MICROALBUMIN CONTROLS
- ARCHITECT MICROALBUMIN REAGENT KIT (500T)
- ARCHITECT SYSTEM - HAVAB-IGG ASSAY
- ARCHITECT SYSTEM - HAVAB-IGG, REAGENT KIT
- ARCHITECT SYSTEM - HAVAB-IGM ASSAY
- ARCHITECT SYSTEM - ICARBAMAZEPINE CALIBRATORS
- ARCHITECT SYSTEM - ICARBAMAZEPINE REAGENT KIT
- ARCHITECT SYSTEM - THEOPHYLLINE ASSAY
- ARCHITECT THYROGLOBULIN CALIBRATORS
- ARCHITECT THYROGLOBULIN CONTROLS
- ARCHITECT THYROGLOBULIN 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.