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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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No Description
SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution

  • 00813545025649 ()
I-ECH01X

  • Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Lyra FLU A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M100
In Commercial Distribution

  • 30014613311003 ()
M100

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Flu kit; 10 test kit
CEPHEID
XPRSFLU-10
In Commercial Distribution

  • 07332940006044 ()
XPRSFLU-10

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
Beckman Coulter, Inc.
447480
In Commercial Distribution

  • 15099590233242 ()
447480

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)
Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
THE BINDING SITE GROUP LIMITED
NK012.10S
In Commercial Distribution

  • 05051700016698 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK012.S
Not in Commercial Distribution

  • 05051700012249 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Combo Veritor Plus CLIA- Waived Flu Kit
BECTON, DICKINSON AND COMPANY
256074
In Commercial Distribution

  • 00382902560746 ()
256074

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066)
BECTON, DICKINSON AND COMPANY
256073
In Commercial Distribution

  • 00382902560739 ()
256073

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
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