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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
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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