Medical device licence · 104879 · Class 2
OC-AUTO MICRO 80 IFOB TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104879
- Licence holder
- Polymedco Inc., Polymedco Cancer Diagnostic Products, LlcCortlandt Manor, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 7, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OC-AUTO MICRO 80 IFOB TEST - BUFFER
- OC-AUTO MICRO 80 IFOB TEST - CALIBRATOR
- OC-AUTO MICRO 80 IFOB TEST - LATEX REAGENT
- OC-AUTO MICRO 80 IFOB TEST - PERSONAL USE KIT
- OC-AUTO MICRO 80 IFOB TEST - POSITIVE CONTROL
- OC-AUTO MICRO 80 IFOB TEST - SAMPLE BOTTLES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.