Medical device licence · 4845 · Class 2
ACCESS IMMUNOASSAY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 14, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 4845
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 14, 1999
- Devices covered
- 46
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS ACTIVE-B12
- ACCESS ACTIVE-B12 CALIBRATORS
- ACCESS ACTIVE-B12 QC
- ACCESS FREE T4
- ACCESS IMMUNO ASSAY SYSTEM - INTACAT PTH ASSAY
- ACCESS IMMUNOASSAY SYSTEM - ACCESS TOTAL BETAHCG (5TH IS) ASSAY
- ACCESS IMMUNOASSAY SYSTEM - SHBG ASSAY
- ACCESS IMMUNOASSAY SYSTEM - TOTAL 25(OH) VITAMIN D
- ACCESS IMMUNOASSY SYSTEM - TPO ANTIBODY ASSAY
- ACCESS SENSITIVE ESTRADIOL
- ACCESS SENSITIVE ESTRADIOL CALIBRATORS
- ACCESS SYSTEM - CORTISOL ASSAY
- ACCESS SYSTEM - DHEA-S ASSAY
- ACCESS SYSTEM - DIGOXIN ASSAY
- ACCESS SYSTEM - EPO (ERYTHROPOIETIN) ASSAY
- ACCESS SYSTEM - ESTRADIOL ASSAY
- ACCESS SYSTEM - FERRITIN ASSAY
- ACCESS SYSTEM - FOLATE ASSAY
- ACCESS SYSTEM - FOLATE CALIBRATORS
- ACCESS SYSTEM - FOLATE S0 CALIBRATOR
- ACCESS SYSTEM - FREE T3 ASSAY
- ACCESS SYSTEM - HAV AB ASSAY
- ACCESS SYSTEM - HAV IGM ASSAY
- ACCESS SYSTEM - HFSH ASSAY(FOLLICLE STIM HORMONE)
- ACCESS SYSTEM - HLH ASSAY(LUTEINIZING HORMONE)
- ACCESS SYSTEM - IL6 (INTERLUKEN6)
- ACCESS SYSTEM - IMMUNOASSAY ANALYZERS CLASS 2
- ACCESS SYSTEM - INHIBIN A
- ACCESS SYSTEM - INTRINSIC FACTOR AB
- ACCESS SYSTEM - OSTASE ASSAY
- ACCESS SYSTEM - PROGESTERONE ASSAY
- ACCESS SYSTEM - PROLACTIN ASSAY
- ACCESS SYSTEM - STFR ASSAY
- ACCESS SYSTEM - TESTOSTERONE ASSAY
- ACCESS SYSTEM - THYROGLOBULIN ANTIBODY II
- ACCESS SYSTEM - THYROGLOBULIN ASSAY
- ACCESS SYSTEM - THYROID UPTAKE ASSAY
- ACCESS SYSTEM - TOTAL T3 ASSAY
- ACCESS SYSTEM - TOTAL T4 ASSAY
- ACCESS SYSTEM - ULTRASENSITIVE INSULIN ASSAY
- ACCESS SYSTEM - UNCONJUGATED ESTRIOL ASSAY
- ACCESS SYSTEM - VITAMIN B12 ASSAY
- ACCESS SYSTEM - WASH BUFFER
- ACCESS SYSTEM ACCESS 2 ANALYZER - CLASS 2
- ACCESS SYSTEM, - ULTRA SENSITIVE HGH ASSAY
- ACESS SENSITIVE ESTRADIOL CALIBRATOR S0
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.