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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The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Kit Box 1
In Commercial Distribution

  • 00859882007023 ()


  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Controls Kit
In Commercial Distribution

  • 00859882007016 ()


  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Calibrators Kit
In Commercial Distribution

  • 00859882007009 ()


  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
EL0311
In Commercial Distribution

  • 10816101022332 ()
EL0311

  • West Nile virus immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0315
In Commercial Distribution

  • 10816101022059 ()
EL0315

  • West Nile virus immunoglobulin M (IgM) antibody IVD, control
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
West Nile Virus Calibrators
Not in Commercial Distribution

  • 15420045500365 ()
301186

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
West Nile Virus TIGRIS Controls
Not in Commercial Distribution

  • 15420045500358 ()
301185

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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

  • 15420045500341 ()
302181

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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

  • 15420045500334 ()
302181

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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

  • 15420045500327 ()
302181

  • West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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