Profile: 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 products that will enable vastly improved outcomes of patients with severe sepsis.
Spectral's EAAT Endotoxin Activity Assay is the only FDA cleared, CE marked rapid diagnostic for endotoxemia. Endotoxin is an early objective marker for severity of sepsis that may not be identified with traditional clinical signs. Spectral holds the exclusive rights for Toraymyxin in the U.S. and Canada, and is currently conducting a Phase III clinical trial for severe sepsis and septic shock.Toraymyxin is a Polymyxin B extracorporeal direct hemoperfusion adsorption column which is highly effective in removing endotoxin in the bloodstream. Spectral provides high quality, high performance biochemicals for research and commercial products. Possessing a long onboard shelf life, Spectral's single-chain Troponin I-C polypeptides, and other reagent products, have been recognized by the market as a premier reagent for large instrument calibration and control.
FDA Registration Number: 9617857
US Agent: Olga Pavlova / Spectral Diagnostics Us, Inc. ( C/o Amarex, Llc)
Phone: +1-(240)-235-6857 Fax: +1-(301)-528-2300 E-Mail:
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• Chemiluminescent Endotoxin Activity Assay (FDA Code: 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. |
• Microbial & Endotoxin Analyses |
• West Nile Virus Antibody Elisa (FDA Code: NOP / 866.3940) West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus. |