Critical components of LDTs
We are registered (#3003830126) with the FDA as a manufacturer of custom Analyte Specific Reagent (ASR) oligonucleotides, for use in in vitro diagnostic (IVD) applications.
Learn more about our manufacturing programs, discuss your project or get a quotation
Class I ASR
We offer a price attractive, customizable manufacturing process to cater to the specifications and use of your Class I ASRs.
Class I ASRs must be labeled as “Analyte Specific Reagent. Analytical and performance characteristics are not established.”
Class II and III ASR
We manufacture ASR oligonucleotides Class II and III under a QMS which is ISO 13485 certified (ISO 13485 is equivalent to 21 CFR part 820 and is recognized by the FDA).