Medical device licence · 94850 · Class 2
D-100 HBA1C HEMOGLOBIN TESTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 12, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94850
- Licence holder
- Bio-Rad Laboratories, Inc.Irvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 12, 2015
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-100 CLEANING TUBE
- D-100 HBA1C
- D-100 HBA1C ANALYTICAL CARTRIDGE/CALIBRATOR PACK
- D-100 HBA1C CALIBRATOR PACK
- D-100 HBA1C ELUTION BUFFER A
- D-100 HBA1C ELUTION BUFFER B
- D-100 HEMOGLOBIN TESTING SYSTEM
- D-100 HEMOGLOBIN TESTING SYSTEM FOR TOTAL LABORATORY AUTOMATION (TLA)
- D-100 HEMOGLOBIN TESTING SYSTEM SOFTWARE VERSION 1.4
- D-100 PREFILTER
- D-100 SAMPLE DILUENT
- D-100 WASH SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.