Medical device licence · 75051 · Class 2
SPAPLUS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed October 3, 2007; ended October 27, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 75051
- Licence holder
- The Binding Site Group LimitedBirmingham, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 3, 2007
- Ended
- October 27, 2022
- Devices covered
- 62
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- C-REACTIVE PROTEIN KIT FOR USE ON SPAPLUS
- ELEVATED RANGE IGG4 KIT SPAPLUS
- HUMAN BETA-2 MICROGLOBULIN CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN C3C CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN C4 CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN CYSTATIN C CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN IGA CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN IGD CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN IGG CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN IGG SUBCLASS CONTROL PACK FOR USE ON THE SPAPLUS
- HUMAN IGM CONTROL PACK FOR USE ON THE SPAPLUS
- IGE KIT SPAPLUS
- SPA PLUS - HUMAN BETA 2-MICROGLOBULIN KIT
- SPA PLUS RHEUMATOID FACTOR (RF) KIT
- SPAPLUS
- SPAPLUS - AUTODIL SAMPLE DILUENT
- SPAPLUS - FERRITIN KIT
- SPAPLUS - FULL RANGE C-REACTIVE PROTEIN KIT
- SPAPLUS - HEVYLITE HUMAN IGA KAPPA KIT
- SPAPLUS - HEVYLITE HUMAN IGA LAMBDA KIT
- SPAPLUS - HEVYLITE HUMAN IGG KAPPA KIT
- SPAPLUS - HEVYLITE HUMAN IGG LAMBDA KIT
- SPAPLUS - HEVYLITE HUMAN IGM KAPPA KIT
- SPAPLUS - HEVYLITE HUMAN IGM LAMBDA KIT
- SPAPLUS - HUMAN ALBUMIN KIT
- SPAPLUS - HUMAN ALPHA1-ACID GLYCOPROTEIN KIT
- SPAPLUS - HUMAN ALPHA1-ANTITRYPSIN KIT
- SPAPLUS - HUMAN ALPHA2-MACROGLOBULIN KIT
- SPAPLUS - HUMAN ANTI-STREPTOLYSIN O KIT
- SPAPLUS - HUMAN BETA-2 MICROGLOBULIN URINE KIT
- SPAPLUS - HUMAN C1 INACTIVATOR KIT
- SPAPLUS - HUMAN C3C KIT
- SPAPLUS - HUMAN C4 KIT
- SPAPLUS - HUMAN CAERULOPLASMIN KIT
- SPAPLUS - HUMAN CH50 CALIBRATOR SET
- SPAPLUS - HUMAN CH50 CONTROLS
- SPAPLUS - HUMAN CH50 REAGENT PACK
- SPAPLUS - HUMAN CYSTATIN C KIT
- SPAPLUS - HUMAN HAPTOGLOBIN KIT
- SPAPLUS - HUMAN IGA 1 KIT
- SPAPLUS - HUMAN IGA 2 KIT
- SPAPLUS - HUMAN IGA LIQUID REAGENT KIT
- SPAPLUS - HUMAN IGD KIT
- SPAPLUS - HUMAN IGG KIT
- SPAPLUS - HUMAN IGG SUBCLASS
- SPAPLUS - HUMAN IGG1 SUBCLASS KIT
- SPAPLUS - HUMAN IGG2 SUBCLASS KIT
- SPAPLUS - HUMAN IGG3 SUBCLASS KIT
- SPAPLUS - HUMAN IGG4 SUBCLASS KIT
- SPAPLUS - HUMAN IGM LIQUID REAGENT KIT
- SPAPLUS - HUMAN MICROALBUMIN KIT
- SPAPLUS - HUMAN PREALBUMIN KIT
- SPAPLUS - HUMAN TRANSFERRIN KIT
- SPAPLUS - LIPOPROTEIN (A) KIT
- SPAPLUS HUMAN ALBUMIN CSF KIT
- SPAPLUS HUMAN ANTI-TETANUS TOXOID IMMUNOGLOBULIN KIT
- SPAPLUS HUMAN IGA CSF KIT
- SPAPLUS HUMAN IGG CSF KIT
- SPAPLUS HUMAN IGM CSF KIT
- SPAPLUS SAMPLE DILUENT
- SPAPLUS-APOLIPOPROTEIN
- SPAPLUS-DILUENT PACK
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 “spaplus”. 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.