𝔖 Bobbio Scriptorium
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FDA's new regulatory paradigms for in vitro diagnostic devices

✍ Scribed by Robinowitz, M.; Gutman, S.I.

Book ID
122183918
Publisher
Informa plc
Year
1999
Tongue
English
Weight
67 KB
Volume
1
Category
Article
ISSN
1465-3249

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## Abstract Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generall