Where can I learn more about Analyte Specific Reagents (ASRs)?

FAQs Standards

More information on ASRs and related requirements can be found with the following documents from FDA:

  • Guidance for Industry and FDA Staff. Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions. FDA. Document issued on: September 14, 2007
  • 21 CFR - Code of Federal Regulations Title 21