Medical device licence · 33559 · Class 2
FREELITE HUMAN KAPPA KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 6, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 33559
- Licence holder
- The Binding Site Group LimitedBirmingham, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 6, 2001
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FREE LITE, KAPPA FREE LIGHT CHAIN KIT, FOR USE ON PROSPEC
- FREELITE HUMAN KAPPA FREE CONTROL PACK FOR USE ON THE ROCHE COBAS C SYSTEMS
- FREELITE HUMAN KAPPA FREE CONTROL PACK FOR USE ON THE SIEMENS BN PROSPEC
- FREELITE HUMAN KAPPA FREE CONTROL PACK FOR USE ON THE SIEMENS BNII
- FREELITE HUMAN KAPPA FREE CONTROL PACK FOR USE ON THE SPAPLUS
- FREELITE HUMAN KAPPA FREE KIT FOR USE ON THE BECKMAN COULTER IMMAGE
- FREELITE HUMAN KAPPA FREE KIT FOR USE ON THE DADE BEHRING BN PROSPEC
- FREELITE HUMAN KAPPA FREE KIT FOR USE ON THE DADE BEHRING NEPHELOMETER BNII
- FREELITE HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS C SYSTEMS
- FREELITE HUMAN KAPPA FREE KIT FOR USE ON THE SPA PLUS
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 “freelite”. A notice may cover another product or only some lots: read it to see what it covers.
- Freelite Human Lambda Free Kit (for use on the SPAPLUS)November 12, 2021 · Medical devices · Inaccurate test or measurement results · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.