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DUŽ 800 UV/Visible Spectrophotometers--Regulatory
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The following documents below are included on the DU 800 CD-ROM* in PDF format or can be downloaded here. The DU 800 System and Applications Software is shipped with the DU 800 instrument on a CD-ROM.
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Certificate of Compliance
Certifies that the DU 800 UV/Vis Spectrophotometer was designed, evaluated, inspected, and tested to approved specified Quality Requirements of Beckman Coulter Incorporated in accordance with ISO 9001 and other Quality, Inspection and Test Requirements/Guidelines.
Also included in printed form with DU 800 System.
Download (PDF Format)
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Declaration of Conformity (Europe)
Declares that the DU 800 UV/Vis Spectrophotometer conforms to the latest European Directives and Standards. This document is a multi-language document
(english, german, italian, french, and spanish).
Also included in printed form with DU 800 System.
Download (PDF Format)
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Software Validation Pack
Documents the requirements and history of the DU 800 System and Applications Software as well as the development environment, algorithms, and support procedures.
To obtain the Software Validation Pack in printed form, please order P/N 512941.
Download (PDF Format)
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Qualification Statement
When upgrading from a DU Series 600 system to a DU 800, this document from Beckman Coulter states that the specifications/results will be identical and that a re-qualification of the system is NOT REQUIRED, if desired.
Download
(PDF Format)
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The DU 800 has been designed to meet the US, British, European, and Australian Pharmacopiea specifications. Some of the critical procedures and protocols are included in the Beckman Coulter test procedures.
* For the latest version of the DU 800 System and Applications Software CD-ROM, please order P/N 512910.
Additional Information:
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