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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name assay, genotype, hiv drug resistance, in vitro
510(K) Number BK000038
Device Name TrueGene HIV Genotyping Kit and OpenGene DNA Sequencing System
Product CodeNHS
Device ClassII
Regulation Number866.3950
Submission Type 510(k) Traditional
Requestor
Visible Genetics, Inc.
700 bay street, suite 1000
toronto,  Ontario M5G 1Z6  CA
Date Received09/12/2000
Decision Date 06/27/2001
DecisionDENOVOGRANT
Expedited Review No
Third Party Review Not Third Party Elligble
In Vitro Device? Yes
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