https://www.fda.gov/regulatory-information/search-fda-guidance-documents/commercially-distributed-analyte-specific-reagents-asrs-frequently-asked-questions
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions | FDA
Regulations regarding commercially distributed analyte specific reagents (ASRs) (21 CFR 809.10(e), 809.30, and 864.4020), and role/responsibilities of manuf.
frequently asked questionsspecific reagentsdistributedanalyteasrs
https://www.techtransfer.nih.gov/patent/e-211-2000-0-jp-03
Method For Generating Phosphorylation Site-Specific Immunologic Reagents | Technology Transfer
site specificmethodgeneratingphosphorylationreagents