I'm pleased to announce that the
HER-2/neu ELISA
was approved by Health Canada today (see attached).
This approval will greatly reduce the burden on our customers
who previously could only purchase the kit through Special Access.
I'd like to thank Don Tenney for all of his support.
With his help we produced a high-quality submission
that only raised a few minor questions during review.
The following parts may now be sold in Canada (with the Special Access restrictions removed):
Part
Part Number
HER-2/neu ELISA
06489876
HER-2/neu ELISA Controls
06489884
Matt Gee
Regulatory Affairs Associate
Siemens Medical Solutions Diagnostics, Inc.
1200 Courtney Park Drive East(new address)
Mississauga, ON L5T 1P2
Tel: 905-795-4539 (new number)
Fax: 905-795-4410 (new number)
Email: matthew.gee@siemens.com