Medical device licence · 8282 · Class 2
COAT-A-COUNT TSH IRMA
No longer licensed: cancelled
Licence status Cancelled; first licensed July 19, 1999; ended January 22, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 8282
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 19, 1999
- Ended
- January 22, 2015
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COAT-A-COUNT BUFFERED WASH SOLUTION
- COAT-A-COUNT CALIBRATORS
- COAT-A-COUNT TSH ANTIBODY COATED TUBES
- COAT-A-COUNT TSH I-125 ANTIBODY
- COAT-A-COUNT TSH IRMA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.