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Reagent stability studies are needed to support shelf-life expiration dates for in vitro diagnostics (IVDs) authorized under an EUA for emergency use during the COVID-19 pandemic, however they generally do not need to be completed at the time of initial review of the EUA request and/or EUA issuance, but should be initiated immediately following authorization, if not before

The inclusion of benzyl alcohol inhibits microbial growth between successive punctures, qualifying this product as a multi-dose diluent suitable for repeated access under aseptic conditions

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For example, free heme triggers macrophage Toll like receptor 4 (TLR4) activation and TNF- production, as well as ROS-mediated NLRP3 inflammasome induction (6770)