Medical device licence · 2767 · Class 3
DIGENE HC2 SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed May 6, 1999; ended May 24, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2767
- Licence holder
- Qiagen Sciences LlcGermantown, MD, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 6, 1999
- Ended
- May 24, 2022
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIGENE DCR/DML SYSTEM SPECIMAN COLLECTION KIT
- DIGENE DML-200 SYSTEM - RAPID CAPTURE SYSTEM
- DIGENE DML-2000 CAPTURE SYSTEM - DNA COLLECTION DEVICE
- DIGENE DML-2000 GC-ID TEST HYBRID CAPTURE II
- DIGENE DML-2000 HPV TEST HYBRID CAPTURE II
- DIGENE DML-2000 HYBRID CAPTURE MICROPLATE SYS. FOR HPV & CT/GC DNA TESTS
- DIGENE DML-2000 HYBRID CAPTURE MICROPLATE SYSTEM FOR HBV DNA TEST
- DIGENE DML-2000 LUMINOMETER
- DIGENE DML-2000 SYSTEM - HYBRID CAPTURE II HBV DNA TEST
- DIGENE DML-2000 SYSTEM - HYBRID CAPTURE II HBV DNA TEST PLUS
- DIGENE DML-2000 SYSTEM CT-ID TEST HYBRID CAPTURE II
- DIGENE DML-2000 SYSTEM CT/GC TEST HYBRID CAPTURE II
- DIGENE DML-2000 SYSTEM HBV TEST HYBRID CAPTURE II
- DIGENE DML-2000 SYSTEM HIV RNA TEST HYBRID CAPTURE II
- DIGENE FEMALE SWAB SPECIMEN COLLECTION KIT
- DIGENE HC2 CT-ID DNA TEST
- DIGENE HC2 CT/GC DNA TEST
- DIGENE HC2 DNA COLLECTION DEVICE
- DIGENE HC2 GC-ID DNA TEST
- DIGENE HC2 HIGH-RISK HPV DNA TEST
- DIGENE HC2 HPV DNA TEST
- DIGENE HC2 SYSTEM SOFTWARE
- DIGENE SPECIMEN TRANSPORT MEDIUM
- DML 3000
- RAPID CAPTURE SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.