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Regulatory information
For In Vitro Diagnostic Use.
The system is CE marked in compliance with Regulation (EU) 2017/746. For In Vitro Diagnostic Use.
History
Revision
23-20484-00
23-20484-01
23-20484(02)
23-20484(03)
Date
Change made
2019-01
Initial release
2019-03
Updated to include translations
2021-10
Added CE compliance statement, updated EU authorized
representative, and changed format of date and
document number.
2023-03
Added "Removing the integration cover" procedure
Updated the following sections:
General system precautions
l
Updated laser classification and safety
l
Precaution labels
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