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Analyte Specific Agents/Laboratory Developed Tests

ASM Statements

Guidance Documents and Rules

February 26, 2003:  Guidance for Industry Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry

November 5, 1998 - Analyte Specific Reagents (ASR) Final Rule
Food and Drug Administration Final Rule on Analyte Specific Reagents (ASR) goes into effect on November 23, 1998. The ASM is working with the FDA on an interpretation of this regulation and its impacts on clinical laboratories.

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