ApprovalTrail

Medical device licence · 30258 · Class 3

A1CNOW

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed June 22, 2001; ended February 26, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
30258
Licence holder
Bayer Healthcare Llc, A Subsidiary Of Bayer CorporationSunnyvale, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
June 22, 2001
Ended
February 26, 2004
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • A1CNOW INVIEW
  • DRX HBA1C KIT

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.