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PyroGeneTM Recombinant Factor C Endotoxin Detection Assay Catalog Number: 50658U, 50658NV Certificate of Analysis at www.lonza.com/coa 50658U1105 12/2/05 11:02 AM Page 2 TABLE OF CONTENTS TITLE PAGE
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What is pyrogenetm recombinant factor c?
Pyrogenetm recombinant factor c is a synthetic form of Factor C protein, which is used as an endotoxin detection method in pharmaceutical and medical device manufacturing.
Who is required to file pyrogenetm recombinant factor c?
Manufacturers and companies in the pharmaceutical and medical device industry are generally required to file pyrogenetm recombinant factor c for endotoxin testing purposes.
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Pyrogenetm recombinant factor c can be filled out by following the instructions provided by the manufacturer of the product or by consulting with a qualified professional in endotoxin testing.
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The purpose of pyrogenetm recombinant factor c is to detect and measure endotoxin levels in pharmaceutical and medical device products to ensure they meet safety and quality standards.
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The information reported on pyrogenetm recombinant factor c typically includes the sample details, test results, and any relevant notes or observations from the testing process.
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