Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

  • Model / Serial
    Lot 2447/ exp 2004-01 Lot 2476/ exp 2003-08-14 Lot 2569/ exp 2003-09-24 Lot 2570/ exp 2003-11 Lot 2577/ exp 2003-09-24 Lot 2646/ exp 2003-08
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
  • Product Description
    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Digene Corp, 1201 Clopper Road, Gaithersburg MD 20878
  • Source
    USFDA