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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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SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution

  • 00813545025649 ()
I-ECH01X

  • Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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)
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)
FACEFIT NIV MASK WITH PORT LARGE
Intersurgical Incorporated
2252030
Not in Commercial Distribution

  • 05030267128273 ()
  • 05030267128266 ()


  • CPAP/BPAP face mask, single-use
FACEFIT NIV MASK WITH PORT MEDIUM
Intersurgical Incorporated
2251030
Not in Commercial Distribution

  • 05030267128259 ()
  • 05030267128242 ()


  • CPAP/BPAP face mask, single-use
FACEFIT NIV MASK WITH PORT SMALL
Intersurgical Incorporated
2250030
Not in Commercial Distribution

  • 05030267128235 ()
  • 05030267128228 ()


  • CPAP/BPAP face mask, single-use
FLO-GUARD BREATHING FILTER
Intersurgical Incorporated
1690000
In Commercial Distribution

  • 05030267105724 ()
  • 05030267104543 ()


  • Microbial medical gas filter, single-use
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