Where can I learn more about Analyte Specific Reagents (ASRs)?
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 Part 864, Section 864.4020