CDRH Updates: New Device Approval: COBAS TaqMan HBV Test For Use With The High Pure System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Read more from the FDA.

MORE ON THIS TOPIC