DNAprint Genomics (DNAG)

[Gcbr]

hope---right from the material you provided.

With the recent approval of Visible Genetics' TruGene genotyping assay as a class II device, FDA has now reclassified these assays as class II devices. In addition, the FDA has developed a draft Guidance Document that is published for comment in the Federal Register. The final revised version of the Guidance Document will also be published in the Federal Register for use by manufacturers in preparing their 510(K) submissions