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 WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
WNV Positive Control
In Commercial Distribution

  • 00850032683067 ()


  • West Nile virus nucleic acid IVD, control
ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.
Lgc Clinical Diagnostics, Inc.
2020-0107
In Commercial Distribution

  • 00816784020901 ()
2020-0107

  • West Nile virus nucleic acid IVD, control
LHK - VIRGINIA HOSPITAL
MEDLINE INDUSTRIES, INC.
VASC1325
In Commercial Distribution

  • 40195327127467 ()
  • 10195327127466 ()
VASC1325

  • General surgical procedure kit, non-medicated, single-use
BFKNSTD Virginia - Refill
Certified Safety Manufacturing, Inc.
FKR208-096
In Commercial Distribution

  • 00766588089966 ()
FKR208-096

  • First aid kit, medicated
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 4
In Commercial Distribution

  • 00859882007054 ()


  • 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.
Kit Box 3
In Commercial Distribution

  • 00859882007047 ()


  • 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.
Kit Box 2
In Commercial Distribution

  • 00859882007030 ()


  • 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.
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)
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