Analyte Specific Reagents (ASR)

Analytical and performance characteristics are not established.

Frequently Asked Questions

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:

  1. In vitro diagnostic manufacturers.
  2. Clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing under 42 CFR part 493 or clinical laboratories regulated under VHA Directive 1106 (available from Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420).
  3. Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

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."

Why Choose BioLegend for ASRs?

 

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.

 

Contact a representative today to discuss your options for ASR products.

Benefits of cGMP

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.
This helps with:

 

  • Ensuring batch-to-batch consistency
  • Documented procedures and employee training
  • Equipment maintenance and monitoring records
  • Materials traceability
  • Lot-specific certificates of analysis
  • QA review of released products
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