Medical device licence · 10149 · Class 2
VARIANT II HEMOGLOBIN TESTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 26, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10149
- Licence holder
- Bio-Rad Laboratories, Inc.Irvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 26, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CDM SOFTWARE IMAGE
- HEMOGLOBIN TESTING SYSTEM - HEMOGLOBIN A1C PROGRAM REORDER PACK
- VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER
- VARIANT II HEMOGLOBIN TESTING SYSTEM - BETA THALASSEMIA SHORT PROGRAM
- VARIANT II HEMOGLOBIN TESTING SYSTEM- VARIANT II TURBO -UPGRADE KIT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “variant”. A notice may cover another product or only some lots: read it to see what it covers.
- VARIANT NBS Newborn Screening System - Sickle Cell Program (2020-02-27)March 13, 2020 · Medical devices · Medical devices · Type III
- MiSeqDx Cystic Fibrosis 139-Variant Assay (2018-02-13)February 22, 2018 · Medical devices · Medical devices · Type III
- Miseqdx Cystic Fibrosis 139-Variant AssayJuly 7, 2017 · Medical devices · Medical devices · Type III
- VARIANT II HEMOGLOBIN TESTING SYSTEM(2015-08-24)October 8, 2015 · Medical devices · Health products · Type III
- Variant II Beta-Thalassemia Short Program (2014-04-25)April 25, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.