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Analyte specific reagents: FDA final rule and implications for your clinical flow cytometry laboratory
1University of Massachusetts Medical School, Department of Pathology and Clinical Laboratories, Berkshire Medical Center, Pittsfield, 01201, USA.
Cytometry
|March 24, 1999
Abstract:
In summary, the FDA Final Rule on Analyte Specific Reagents has provided clarity and simplification for manufactures to develop and market products. The burden of establishing performance characteristics is now the responsibility of the clinical flow cytometry laboratory. The FDA now requires a disclaimer to be included in every lab report utilizing these products.

