Medical device licence · 11697 · Class 2
CLINITEK HCG
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed October 8, 1999; ended November 5, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 11697
- Licence holder
- Bayer Healthcare Llc Subsidiary Of Bayer CorporationMishawaka, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 8, 1999
- Ended
- November 5, 2005
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CINITEK HCG TEST STRIPS
- CLINITEK HCG
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 “clinitek”. A notice may cover another product or only some lots: read it to see what it covers.
- CLINITEK Status System - Urine Chemistry Analyzer (2020-02-10)February 28, 2020 · Medical devices · Medical devices · Type III
- Clinitek Atlas Automated Urine Chemistry SystemSeptember 11, 2017 · Medical devices · Type III
- CLINITEK Status+ (2016-01-25)February 12, 2016 · Medical devices · Medical devices · Type III
- CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM- CONTROL STRIPS (2016-01-26)February 8, 2016 · Medical devices · Medical devices · Type III
- CLINITEK NOVUS 10 AND PRO 10 URINALYSIS CASSETTES (2015-12-21)January 14, 2016 · Medical devices · Health products · Type III
- CLINITEK NOVUS ANALYZER (WITH RACK) (2015-07-02)July 17, 2015 · Medical devices · Health products · Type III
- CLINITEK Novus Automated Urine Chemistry Analyzers (2015-01-15)February 16, 2015 · Medical devices · Health products · Type III
- CLINITEK Novus Automated Urine Chemistry Analyzers (2015-01-28)February 16, 2015 · Medical devices · Health products · Type III
- Clinitek Novus Automated Urine Chemistry Analyzer (with and without rack handler) (2014-11-10)November 20, 2014 · Medical devices · Medical devices · Type III
- Clinitek Status System-Urine Chemistry Analyzer (2014-09-24)October 9, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.