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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 Size Type Device Class Implantable

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Influenza B Monoclonal Antibody
EMD Millipore Corporation
5002
Not in Commercial Distribution

  • 04053252330094 ()
5002

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Influenza A FITC-Labeled Monoclonal Antibody
EMD Millipore Corporation
5017
Not in Commercial Distribution

  • 04053252320439 ()
5017

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
SimulFluor® Flu A / Flu B Reagent
EMD Millipore Corporation
5250-5ML
Not in Commercial Distribution

  • 04053252270239 ()
5250-5ML

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)
Influenza A & B Control Slide
EMD Millipore Corporation
5010
Not in Commercial Distribution

  • 04053252789229 ()
5010

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Influenza B Monoclonal Antibody
EMD Millipore Corporation
5018
Not in Commercial Distribution

  • 04053252473722 ()
5018

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Influenza A Monoclonal Antibody
EMD Millipore Corporation
5001
Not in Commercial Distribution

  • 04053252470226 ()
5001

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Duet DFA Influenza A/Respiratory Virus Screening kit
DIAGNOSTIC HYBRIDS, INC.
01-200000
In Commercial Distribution

  • 30014613330882 ()
01-200000

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
FASTPOINT FLUA/B KIT BX 2
DIAGNOSTIC HYBRIDS, INC.
01-120001.B2
In Commercial Distribution

  • 30014613330806 ()
01-120001.B2

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT BX 1
DIAGNOSTIC HYBRIDS, INC.
01-120001.B1
In Commercial Distribution

  • 30014613330790 ()
01-120001.B1

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT
DIAGNOSTIC HYBRIDS, INC.
01-120001
In Commercial Distribution

  • 30014613330783 ()
01-120001

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
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