august-Back2schoolhero

ASM's Top 5 Textbooks

Helping educators teach tomorrow's microbiologists.
Read

Teach Undergraduates to Think Like Scientists

High quality resources from ASM to inform your teaching.
Read

Videos for Improving Learning

Videos from Microbe 2016 to improve your courses.
Read


New Governance Information
VOTE
Become a member today!
JOIN ASM
Submit Abstracts for ABRCMS
SUBMIT
Register for ABRCMS
REGISTER

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.

TPL_asm2013_SEARCH

2715