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VGI Trugene HIV-1 Test Downclassification Petition Anticipated By August

This article was originally published in The Gray Sheet

Executive Summary

Visible Genetics, Inc. plans to submit a petition to FDA by August seeking classification of its Trugene HIV-1 genotyping test and OpenGene DNA sequencing system as Class II following FDA's rejection of a September 2000 510(k) submission.

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