Analytical and performance characteristics are not established.
What is ASR?
Analyte Specific Reagents (ASR) are 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 for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.
To Whom Can Manufacturers Sell ASRs?
In the USA, ASR's may only be sold to:
Can The Manufacturer Include Instructions With An ASR?
ASR products are intended for laboratory developed tests (LDTs) and IVD manufacturers. ASR manufacturers should not provide instructions for developing or performing an assay with an ASR, nor make claims to physicians or laboratories regarding analytical or clinical performance for ASRs.
The laboratory that develops an in-house test using the ASR shall inform the ordering person of the test result by appending to the test report the statement: "This test was developed and its performance characteristics determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration."
We are a leading developer and manufacturer of world-class, cutting-edge reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. We have extended our expertise to develop high-quality ASR products with the same unwavering commitment to superior customer support and our 100% satisfaction guarantee.
To further our commitment to providing value, consistency, and flexibility for customer workflows, we have scaled up manufacturing to enable reservations for large numbers of vials within the same lot.
Our ASR products strictly adhere to the requirements of our ISO 13485:2016-certified quality management system, and are manufactured in accordance with US 21 CFR Part 820 in an ISO 13485:2016 and MDSAP certified facility.
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