Medical device licence · 111071 · Class 2
MY5-FU
Yes: licensed in Canada
Licence status Issued (active); first licensed April 10, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111071
- Licence holder
- Saladax Biomedical IncBethlehem, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 10, 2024
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MY5-FU 5-FLUOROURACIL ASSAY KIT
- MY5-FU 5-FLUOROURACIL CALIBRATOR KIT
- MY5-FU 5-FLUOROURACIL CONTROL KIT
- MY5-FU SAMPLE STABILIZER
- MY5-FU SAMPLE STABILIZER PACK (20 COUNT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.