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Chemiluminescent Endotoxin Activity Assay Suppliers

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Spectral Medical Inc. | Address: 135 The West Mall, Unit 2, Toronto, Ontario M9C 1C2, Canada Canada
www.spectraldx.com | Send Inquiry | Phone: +1-(416)-6263233
FDA Registration: 9617857
Products: Microbial & Endotoxin Analyses, West Nile Virus Antibody Elisa (FDA Code: NOP), Chemiluminescent Endotoxin Activity Assay (FDA Code: NGS), ...
Spectral Medical Inc. is committed to decreasing the high mortality rates caused by sepsis. By combining complementary diagnostics and therapeutics, or theranostics, Spectral's vision is to provide pr more...
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 EMAIL INQUIRY to  1 Chemiluminescent Endotoxin Activity Assay suppliers  
FDA Code / Regulation: NGS / 866.3210

An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.

Classification. Class II (special controls). The special control for this device is the FDA guidance entitled "Class II Special Controls Guidance Document: Endotoxin Assay." See 866.1(e) for the availability of this guidance document.

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