Ping, I think you are a little confused. The device being sold now in the EU/Japan and Canada does not require use with the endotoxin assay. Spectral diagnostics has an endotoxin assay on the market and that led to a logical deal with Toray where they would in the future promote the diagnostic and the treatment in what is know as a theranostics approach. As for where it can be used, as others have pointed out, both devices require trained medical personnel that usually are in ICU's surgical units and other speciality areas of the hospital. This is common for any hemoperfusion device.
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