Gold Standard Diagnostics provides documentation for all products which have been manufactured by our companies. Documents available include:
User instructions for kits
User instructions for devices
The manufacturer's declaration, that the manufactured product – batch – was conform according to the quality system.
Contains information about material/mixture compositions, hazards, safety handling and storage.
Excel sheet used for evaluating result based on raw data received by using diagnostic kits.
Self declaration for CE marking, issued by the manufacturer.
The manufacturer's declaration, that the manufactured product – batch – was conform according to the quality system. Additionally, this is supported by quality control analysis/measurement data.
Validation report issued at the end of development, that provides specification and performance information for customers.
CE certification document issued by international or European notified test bodies.
Certification issued by specific certification bodies, connected to country requirements.