A Guide to Medical Device Relabeling in the EU
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Quantitative HBV RTPCR Kit
Qualitative HBV RT PCR Kits and Principle of Operation
Qualitative HBV RT PCR Kits Intended use, Class, Product Code, and Regulation Number
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Performance Evaluation of Qualitative HBV RT PCR Kits
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Clinical Performance Studies
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