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Analyte Specific Reagents

Registered with the FDA

LGC Biosearch Technologies is registered with the FDA under registration #3003009052 as a Medical Device Class I Analyte Specific Reagents (ASR) manufacturer.

ASR by definition is a class of oligos intended for in-house testing applications conducted by in vitro diagnostic manufacturers, Clinical Laboratory Improvement Amendments (CLIA) regulated clinical labs, and other institutions who use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners.

Custom ASR Manufacturing and Labeling

LGC Biosearch manufactures custom ASR oligos that are fully in compliance with Federal regulations 21CFR820. Depending upon customer requirements and application, we synthesize custom ASR oligos utilizing a variety of purification techniques able to meet purity specs ≥90%.

Please note that according to 21CFR809.30(d), Class I ASRs must be labeled as “Analyte Specific Reagent. Analytical and performance characteristics are not established.”

As the inventors of the Black Hole Quencher® (BHQ®) dyes, LGC Biosearch is the only custom ASR manufacturer able to synthesize probes and primers labeled with BHQ dyes.  BHQ dyes have no native fluorescence and can quench fluorophores across the entire visible spectrum.  Learn more about LGC Biosearch's series of Black Hole Quencher dyes.

If this caliber of oligos is what you require, request a Contract GMP Manufacturing Brochure e-brochure or contact us at info@biosearchtech.com or 1.800.GENOME.1 (436.6631) and we will gladly discuss and consult you through the needs of your project.