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U.S. Department of Health and Human Services

Product Classification

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Device assay, endotoxin activity, chemiluminescent
Regulation Description Endotoxin assay.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNGS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: Endotoxin Assay [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080609.htm] 
Third Party Review Not Third Party Eligible
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