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Equipment and Method Selection

Availability of Methods

A catalog of cleared and approved medical device information from the FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and other consumer information. Devices@FDA searches the following databases: PMN-510(k) Premarket Notification; PMA-Premarket Approval; and HDE-Humanitarian Device Exemption.

Last Updated on Wednesday, 31 July 2013 11:10

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Validation Methods

 Cumitech 31A: Verification and Validation of Procedures in the Clinical Microbiology Laboratory
Focusing on the common qualitative and semi–quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use.  Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance.  

Clark, R. B., M. A. Lewinski, M. J. Loeffelholz, and R. J. Tibbetts. 2009. Cumitech 31A, Verification and Validation of Procedures in the Clinical Microbiology Laboratory. Coordinating ed., S. E. Sharp. ASM Press, Washington, DC.

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

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Last Updated on Wednesday, 18 June 2014 09:30

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