Analyte Specific Reagents (ASRs)

Analyte Specific Reagent, or ASR, is the designation of an oligonucleotide that is produced for in vitro diagnostic manufacturers, CLIA regulated clinical labs, or organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners.  There are three levels of ASRs depending on the method in which the oligo is used.

Oligos Etc. is registered with the FDA as a Class I ASR manufacturer.  According to 21CFR809.30 (d), Class I ASRs:  "Analyte Specific Reagent.  Analytical and performance characteristics are not established."  No other statement regarding analytical or clinical performance is made. 

At Oligos Etc., oligonucleotide ASRs are prepared synthetically in a range of purities, depending on customer specifications, from 80% to >95% (as determined by analytical ion exchange HPLC).  All ASR oligos are manufactured in compliance with Federal regulations from 21CFR820 and 21CFR864.4020.  We invite you to discuss your project's specific needs.  Contact our Technical Service staff at 800-888-2358 or oligos@oligosetc.com.