Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
West Nile Virus 5K
Not in Commercial Distribution

  • 15420045500310 ()
302181

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
PERIOSTEAL WEST, 18,5 CM
BMT Medizintechnik GmbH
WEST
In Commercial Distribution

  • 04251725218089 ()
WEST

  • Periosteal elevator, reusable
No Description
DIASORIN MOLECULAR LLC
EL0306
In Commercial Distribution

  • 10816101022325 ()
EL0306

  • West Nile virus immunoglobulin G (IgG) antibody IVD, calibrator
No Description
INBIOS INTERNATIONAL, INC
WNMS1
In Commercial Distribution

  • B379WNMS11 ()
WNMS-1

  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2662-9601 M
In Commercial Distribution

  • 04049016028185 ()


  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2662-9601 G
In Commercial Distribution

  • 04049016028178 ()


  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300M-5
In Commercial Distribution

  • 20816101022032 ()
EL0300M-5

  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300M
In Commercial Distribution

  • 20816101022025 ()
EL0300M

  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G-5
In Commercial Distribution

  • 20816101022018 ()
EL0300G-5

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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