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View the U.S. FDA CLIA database information for the i-STAT System (300 series). Select a cartridge type and choose the test complexity. Print this information for inclusion with state laboratory license applications or organizational new product acquisition packets. Links to the FDA’s 510k submission summaries are provided.
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.
Moderate Complexity: The lesser of two test categorizations that comprise non-waived testing; the other category is high complexity testing.
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