Medical device licence · 62637 · Class 2
D-10 HAEMOGLOBIN TESTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 3, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62637
- Licence holder
- Bio-Rad Laboratories, Inc.Irvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 3, 2003
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-10 HAEMOGLOBIN TESTING SYSTEM - DUAL PROGRAM (HBA2/E/AIC)
- D-10 HAEMOGLOBIN TESTING SYSTEM - HBA1C KIT
- D-10 HEMOGLOBIN A1C PROGRAM
- D-10 HEMOGLOBIN TESTING SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.