Medical device licence · 97310 · Class 2
DRG:HYBRID-XL
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97310
- Licence holder
- Drg International, Inc.Springfield, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 15, 2016
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRG:HYBRID-XL
- DRG:HYBRID-XL 17-OH PROGESTERONE
- DRG:HYBRID-XL 25-OH VITAMIN D (TOTAL)
- DRG:HYBRID-XL ALDOSTERONE
- DRG:HYBRID-XL ANDROSTENEDIONE
- DRG:HYBRID-XL CORTISOL
- DRG:HYBRID-XL CRP
- DRG:HYBRID-XL CRP-HS
- DRG:HYBRID-XL CYSTATIN C
- DRG:HYBRID-XL D-DIMER
- DRG:HYBRID-XL DHEA
- DRG:HYBRID-XL DHEA-S
- DRG:HYBRID-XL ESTRADIOL
- DRG:HYBRID-XL FREE T3
- DRG:HYBRID-XL FREE T4
- DRG:HYBRID-XL FREE TESTOSTERONE
- DRG:HYBRID-XL FSH
- DRG:HYBRID-XL HBA1C
- DRG:HYBRID-XL HEPCIDIN 25 (BIOACTIVE)
- DRG:HYBRID-XL INSULIN
- DRG:HYBRID-XL LH
- DRG:HYBRID-XL PROGESTERONE
- DRG:HYBRID-XL PROLACTIN
- DRG:HYBRID-XL RENIN (ACTIVE)
- DRG:HYBRID-XL T3
- DRG:HYBRID-XL T4
- DRG:HYBRID-XL TESTOSTERONE
- DRG:HYBRID-XL TSH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.