Does PrimeSyn Lab Inc. manufacture Analyte Specific Reagent (ASR) or cGMP quality oligo nucleotide?
PrimeSyn Lab Inc. is registered with the U.S. Food and Drug Administration as a Medical Device Class 1 manufacturer for Analyte Specific Reagent (ASR) products, which includes custom nucleic acid sequences for: in vitro diagnostic manufacturers, clinical laboratories or organizations that use the reagent to make tests for purposes other than providing diagnostic information to patients and practitioners. Note: According to 21CFR809.30 (d), Class I ASRs must be labeled as: “Analyte Specific Reagent. Analytical and performance characteristics are not established.” PrimeSyn Lab’s ASR products are manufactured under good manufacturing practices (cGMP) in compliance with FDA regulations 21CFR864.4020 and 21CFR820.
