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U.S. Department of Health and Human Services

Product Classification

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Device antibodies,saccharomyces cerevisiae (s.cerevisiae)
Regulation Description Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNBT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5785
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092789.htm] 
Third Party Review Not Third Party Eligible
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