Food and Drug Administration

Microbiology Devices Panel

March 8, 2002

Briefing Information

P890064/S009 Digene High-Risk HPV DNA Test HYBRID CAPTUREŽ 2


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

  Draft Summary of Safety and Effectiveness Data (Not edited by FDA for accuracy)  pdf