GE Biacore X100 - Regulatory Information Overview

1.3 Regulatory information
Introduction
This section lists the regulations and standards that apply to the Biacore X100 system.
Manufacturing information
The table below summarizes the required manufacturing information.
InformationRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala, Sweden
In this section
See pageSection
91.3.1 EU Directives
101.3.2 Eurasian Customs Union
111.3.3 Regulations for USA and Canada
121.3.4 Korean regulatory information
131.3.5 Other regulations and standards
8 Biacore X100 Operating Instructions 28961142 AD
1 Introduction
1.3 Regulatory information