ApprovalTrail

Medical device licence · 72209 · Class 3

QUANTIFERON-TB GOLD PLUS

Yes: licensed in Canada

Licence status Issued (active); first licensed August 21, 2006. It is in Health Canada’s list of active licences.
Licence number
72209
Licence holder
Qiagen Sciences LlcGermantown, MD, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
August 21, 2006
Devices covered
4

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • QUANTIFERON-B GOLD PLUS - BLOOD COLLECTION TUBES
  • QUANTIFERON-TB GOLD PLUS - HIGH ALTITUDE (HA) BLOOD COLLECTION TUBES
  • QUANTIFERON-TB GOLD PLUS - REFERENCE LAB PACK ELISA KIT
  • QUANTIFERON-TB GOLD PLUS -2 PLATE ELISA KIT

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.