Medical device licence · 99538 · Class 3
HPA BEADCHIP KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 11, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99538
- Licence holder
- Bioarray Solutions Ltd.Warren, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- August 11, 2017
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLEAN-UP REAGENT
- EMAP ELONGATION MIX
- HOTSTARTAQ DNA POLYMERASE
- HPA BEADCHIP CARRIER
- HPA BEADCHIP TM KIT
- HPA BEADCHIP TM KIT (CARRIERS)
- HPA BEADCHIP TM KIT (REAGENTS)
- HPA EMAP PCR MIX
- LAMBDA EXONUCLEASE
- NEGATIVE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.