Medical device licence · 101595 · Class 2
ZYMUTEST VWF CBA
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 13, 2018; ended October 29, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101595
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 13, 2018
- Ended
- October 29, 2020
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-(H)-VWF-HRP IMMUNOCONJUGATE
- COATED MICRO ELISA PLATE
- CONJUGATE DILUENT
- SAMPLE DILUENT
- STOP SOLUTION
- TETRAMETHYLBENZIDINE
- VWF CALIBRATOR
- VWF PLASMA CONTROL I (HIGH)
- VWF PLASMA CONTROL II (LOW)
- WASH SOLUTION
- ZYMUTEST VWF:CBA ELISA
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 “zymutest”. A notice may cover another product or only some lots: read it to see what it covers.
- ZYMUTEST HIA MonoStrip IgG & IgGAM(2019-07-23)August 9, 2019 · 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.