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searching for Laboratory developed test 3 found (9 total)

alternate case: laboratory developed test

C-reactive protein (5,497 words) [view diff] no match in snippet view article find links to article

United States this would represent off-label use, making it a laboratory-developed test under FDA regulations. In healthy adults, the normal concentrations

Sequenom (2,028 words) [view diff] no match in snippet view article find links to article

to collaborate in the development and launch of a trisomy 21 laboratory-developed test and other aneuploidies testing in Germany, Austria, Switzerland

Validation and verification (medical devices) (428 words) [view diff] no match in snippet view article

Parameter(s) Verification of FDA-approved device Validation of a laboratory-developed test Accuracy and precision Yes Yes Reportable range Yes Yes Analytical