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In Brief: Gull Laboratories

This article was originally published in The Gray Sheet

Executive Summary

Gull Laboratories: Receives 510(k) clearance for its semi-quantitative Mumps IgG Elisa test as an aid in the diagnosis of infection caused by the mumps virus, the Salt Lake City-based firm says. Users of the test, which provides results in approximately 90 minutes, have the option to run either one 8-well strip at a time or the full 96-well microtiter plate. Data shows that the test has a relative sensitivity of 97.5% and a relative specificity of 100%...
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