Analyte Specific Reagent (ASR)
Oligos, Etc. is registered with the FDA as a Class I ASR manufacturer.
An Analyte Specific Reagent, as defined by 21 CFR 864.4020, is an “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” The Federal regulations that govern this category of material limits sale to:
· Clinical Laboratories (regulated under Clinical Laboratory Improvement Amendments or CLIA)
· In vitro diagnostic manufacturers
· Organizations that use the reagents to make tests for purposes other than providing diagnostic information (e.g., forensics)
The regulations further classify the reagent depending on the purpose of the in-house test. Contact us at Oligos Etc. to discuss your project’s needs at Ordermanagement@oligosetc.com or 503.682.1814.