Manufacturers

Digene Corp

4 devices in the database

Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
  • Model / Serial
    Lot 2443/ exp 2002-12-02
  • Product Classification
    Immunology and Microbiology Devices
  • 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
    Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296
  • Model / Serial
    Lot 2436/ exp 2003-11
  • Product Classification
    Immunology and Microbiology Devices
  • 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
    Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.
  • Model / Serial
    Lot 2759/ exp 2003-08-31
  • Product Classification
    Immunology and Microbiology Devices
  • 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 # 5196-1230, labeled for export only.
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
    Immunology and Microbiology Devices
  • 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

One manufacturer with a similar name

Learn more about the data here

Digene Corp
  • Manufacturer Address
    Digene Corp, 1201 Clopper Rd, Gaithersburg MD 20878-4000
  • Source
    USFDA