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Monthly Archives: July 2018

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E&L Chemical Characterization & Hexane Extracts: GC vs. LCUVMS Analysis

Category : Analytical, Chemical Characterization, Extractable/Leachable, Medical Device testing

As a contract laboratory providing extractables and leachables (E&L) services we are often asked about the time and cost required to perform chemical characterization of a medical device. Per FDA definition and guidance: Latest Guidance on Device Classification “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” Herein lies the

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