Welcome to the Laboratory Regulations & Compliance Information
section of Abbott Point of Care.

FDA Test
Categorizations
See the waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result. and/or moderate complexity Moderate Complexity: The lesser of two test categorizations that comprise non-waived testing; the other category is high complexity testing. FDA Test Categorizations for the i-STAT 1 System
CLIA &
Accrediting
Organizations
Find out how to acquire the CLIA CLIA: The Clinical Laboratory Improvement Amendments of 1988, established to improve the quality of laboratory testing no matter where the testing is performed. regulations or selected laboratory accrediting organization’s requirements
Additional
Resources
Get contact information for state laboratory office, fees for CLIA certificates, and coding information by state
Customer
Support
Visit the Customer
Support section for answers to additional questions
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