Medical device licence · 66759 · Class 2
AIA-360 IMMUNOASSAY ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66759
- Licence holder
- Tosoh CorporationTokyo, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 8, 2004
- Devices covered
- 68
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AIA-360 ANALYZER SYSTEM - BETA2 MICROGLOBULIN ASSAY
- AIA-360 ANALYZER SYSTEM - CORT (CORTISOL) ASSAY
- AIA-360 ANALYZER SYSTEM - E2 (ESTRADIOL) ASSAY
- AIA-360 ANALYZER SYSTEM - FER (FERRITIN) ASSAY
- AIA-360 ANALYZER SYSTEM - FSH (FOLLICAL STIMULATING HORMONE) ASSAY
- AIA-360 ANALYZER SYSTEM - FT3 (FREE T3) ASSAY
- AIA-360 ANALYZER SYSTEM - FT4 (FREE T4) ASSAY
- AIA-360 ANALYZER SYSTEM - HCG ASSAY
- AIA-360 ANALYZER SYSTEM - HGH (HUMAN GROWTH HORMONE) ASSAY
- AIA-360 ANALYZER SYSTEM - IGE II ASSAY
- AIA-360 ANALYZER SYSTEM - INSTRUMENT
- AIA-360 ANALYZER SYSTEM - INSTRUMENT REAGENTS
- AIA-360 ANALYZER SYSTEM - INTACT PTH (PARATHYROID HORMONE) ASSAY
- AIA-360 ANALYZER SYSTEM - IRI (INSULIN) ASSAY
- AIA-360 ANALYZER SYSTEM - LH II (LUTEINIZING HORMONE) ASSAY
- AIA-360 ANALYZER SYSTEM - PRL (PROLACTIN) ASSAY
- AIA-360 ANALYZER SYSTEM - ST AIA-PACK CYSTATIN C ASSAY
- AIA-360 ANALYZER SYSTEM - T-U (THYROID UPTAKE) ASSAY
- AIA-360 ANALYZER SYSTEM - T4 ASSAY
- AIA-360 ANALYZER SYSTEM - TESTOSTERONE ASSAY
- AIA-360 ANALYZER SYSTEM - TSH (THYROID STIMULATING HORMONE) ASSAY
- AIA-360 ANALYZER SYSTEM - TT3 ASSAY
- AIA-360 ANALYZER SYSTEM- ST AIA-PACK BHCG ASSAY
- AIA-PACK ACTH CONTROL SET
- AIA-PACK C-PEP CONTROL SET
- AIA-PACK D-DIMER CONTROL SET
- AIA-PACK FER CALIBRATION VERIFICATION/LINEARITY TEST
- AIA-PACK FSH CALIBRATION VERIFICATION/LINEARITY TEST
- AIA-PACK HCG CALIBRATION VERIFICATION/LINEARITY TEST
- AIA-PACK HCY CONTROL SET
- AIA-PACK OSTEOCALCIN CONTROL SET
- AIA-PACK PAP CALIBRATION VERIFICATION/LINEARITY TEST
- AIA-PACK PAP CALIBRATOR SET
- AIA-PACK PAP SAMPLE DILUTING SOLUTION
- AIA-PACK PRL CALIBRATION VERIFICATION/LINEARITY TEST
- AIA-PACK PROGIII CALIBRATOR SET
- AIA-PACK SHBG CONTROL SET
- ST AIA-PACK ACTH
- ST AIA-PACK ACTH CALIBRATOR SET
- ST AIA-PACK ACTH SAMPLE DILUTING SOLUTION
- ST AIA-PACK BHCGII
- ST AIA-PACK BHCGII CALIBRATOR SET
- ST AIA-PACK BHCGII SAMPLE DILUTING SOLUTION
- ST AIA-PACK C-PEP II
- ST AIA-PACK C-PEP II CALIBRATOR SET
- ST AIA-PACK C-PEP II SAMPLE DILUTING SOLUTION
- ST AIA-PACK D-DIMER
- ST AIA-PACK D-DIMER CALIBRATOR SET
- ST AIA-PACK D-DIMER SAMPLE DILUTING SOLUTION
- ST AIA-PACK DHEA-S
- ST AIA-PACK DHEA-S CALIBRATOR SET
- ST AIA-PACK DHEA-S SAMPLE DILUTING SOLUTION
- ST AIA-PACK HCY
- ST AIA-PACK HCY CALIBRATOR SET
- ST AIA-PACK HCY PRETREATMENT SET
- ST AIA-PACK HCY SAMPLE DILUTING SOLUTION
- ST AIA-PACK OSTEOCALCIN
- ST AIA-PACK OSTEOCALCIN CALIBRATOR SET
- ST AIA-PACK OSTEOCALCIN SAMPLE DILUTING SOLUTION
- ST AIA-PACK PAP
- ST AIA-PACK PROG II
- ST AIA-PACK PROG II CALIBRATOR SET
- ST AIA-PACK PROG II SAMPLE DILUTING SOLUTION SET
- ST AIA-PACK PROGIII
- ST AIA-PACK PROGIII SAMPLE DILUTING SOLUTION
- ST AIA-PACK SHBG
- ST AIA-PACK SHBG CALIBRATOR SET
- ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.