Medical device licence · 2725 · Class 2
MICROSCAN RAPID PANELS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 3, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 2725
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 3, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MICROSCAN RAPID NEG COMBO PANEL
- MICROSCAN RAPID NEG ID PANEL
- MICROSCAN RAPID NEG URINE COMBO PANEL
- MICROSCAN RAPID POS PANEL
- MICROSCAN RAPID URINE COMBO PANEL
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 “microscan”. A notice may cover another product or only some lots: read it to see what it covers.
- MicroScan Neg/Urine Combo Panel and LabPro Data Management System (2019-05-07)January 10, 2020 · Medical devices · Medical devices · Type II
- MicroScan Pos Combo Panels 29, 33, and 34, MicroScan Pos BP Combo Panel Type 20 (2019-03-20)April 12, 2019 · Medical devices · Medical devices · Type III
- Microscan Pos Combo Panel Type 43 and Mic Panel Type 34 (2017-04-17)May 16, 2017 · Medical devices · Medical devices · Type III
- MICROSCAN POS COMBO and POS BREAKPOINT COMBO (2015-11-23)November 23, 2015 · Medical devices · Health products · Type II
- MICROSCAN LABPRO INFORMATION MANAGER SYSTEM (2015-07-21)August 10, 2015 · Medical devices · Health products · Type II
- MICROSCAN MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH) (2015-06-08)July 21, 2015 · Medical devices · Health products · Type III
- Microscan Rapid Neg Urine Combo Panel (2014-10-22)November 7, 2014 · Medical devices · Medical devices · Type II
- Microscan NEG BP Combo Panel(2014-05-20)June 5, 2014 · 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.