Medical device licence · 1549 · Class 3
PHADEBACT CHLAMYDIA
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed February 25, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 1549
- Licence holder
- Bactus AbHuddinge, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- February 25, 1999
- Ended
- February 16, 2004
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PHADEBACT CHLAMYDIA EIA CERVIX SPECIMEN COLLECTION
- PHADEBACT CHLAMYDIA EIA ENZYME IMMUNOASSAY
- PHADEBACT CHLAMYDIA EIA URETHRA SPECIMEN COLLECTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.