Medical device licence · 6868 · Class 2
STREPTOCOCCAL GROUPING KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 6868
- Licence holder
- Oxoid LimitedNepean, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 30, 1999
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXTRACTION ENZYME
- STREPTOCOCCAL GROUPING KIT
- STREPTOCOCCAL GROUPING REAGENT A
- STREPTOCOCCAL GROUPING REAGENT B
- STREPTOCOCCAL GROUPING REAGENT C
- STREPTOCOCCAL GROUPING REAGENT D
- STREPTOCOCCAL GROUPING REAGENT F
- STREPTOCOCCAL GROUPING REAGENT G
- STREPTOCOCCAL POLYVALENT POSITIVE CONTROL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “streptococcal”. A notice may cover another product or only some lots: read it to see what it covers.
- Prolex Streptococcal Xtra Select Kit (2019-03-03)April 5, 2019 · Medical devices · Medical devices · Type III
- Streptococcal Grouping Reagent Particle Suspension Group C (2018-12-03)January 11, 2019 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.