Medical device licence · 79382 · Class 2
QUICKGEL ELECTROPHORESIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 26, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79382
- Licence holder
- Helena Laboratories, CorpBeaumont, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 26, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- QUICKGEL - ACID HEMOGLOBIN KIT
- QUICKGEL - ALKALINE HEMOGLOBIN KIT
- QUICKGEL - ELECTROPHORESIS CHAMBER
- QUICKGEL - IMMUNOFIX (IFE) KIT
- QUICKGEL - LD ISOENZYME KIT
- QUICKGEL - LIPOPROTEIN KIT
- QUICKGEL - SERUM PROTEIN (SPE) KIT
- QUICKGEL SPE (BLADE APPLICATION)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.