# Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System (BK020005)

_Visible Genetics, Inc. · Apr 24, 2002 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK020005

## Device Facts

- **Applicant:** Visible Genetics, Inc.
- **Decision Date:** Apr 24, 2002
- **Decision:** SESE

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**Source:** [https://fda-staging.innolitics.com/device/BK020005](https://fda-staging.innolitics.com/device/BK020005)

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