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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 Class Implantable

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Procleix - 15420045500310

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)

West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator - 10816101022325

No Description
DIASORIN MOLECULAR LLC
EL0306
In Commercial Distribution

  • 10816101022325 ()
EL0306

  • West Nile virus immunoglobulin G (IgG) antibody IVD, calibrator

Anti-West Nile Virus ELISA (IgM) - 04049016028185

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)

Anti-West Nile Virus ELISA (IgG) - 04049016028178

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)

West Nile Detect IgM Capture ELISA - B379WNMS11

No Description
INBIOS INTERNATIONAL, INC
WNMS1
In Commercial Distribution

  • B379WNMS11 ()
WNMS-1

  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

West Nile Virus IgM Capture DxSelect™ - 20816101022032

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)

West Nile Virus IgM Capture DxSelect™ - 20816101022025

No Description
DIASORIN MOLECULAR LLC
EL0300M
In Commercial Distribution

  • 20816101022025 ()
EL0300M

  • West Nile virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

West Nile Virus IgG DxSelect™ - 20816101022018

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)

West Nile Virus IgG DxSelect™ - 20816101022001

No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

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

VIROTROL - 00847661002628

VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
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