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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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HemosIL Routine Control Level 3
INSTRUMENTATION LABORATORY COMPANY
00020005800
In Commercial Distribution

  • 08426950573401 ()
  • 18426950573408 ()
00020005800

  • Multiple coagulation factor IVD, control
HemosIL Routine Control Level 2
INSTRUMENTATION LABORATORY COMPANY
00020005700
In Commercial Distribution

  • 08426950573395 ()
  • 18426950573392 ()
00020005700

  • Multiple coagulation factor IVD, control
HemosIL Routine Control Level 1
INSTRUMENTATION LABORATORY COMPANY
00020005600
In Commercial Distribution

  • 08426950573388 ()
  • 18426950573385 ()
00020005600

  • Multiple coagulation factor IVD, control
HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
IAN-1110
In Commercial Distribution

  • B110IAN11100 ()
IAN-1110

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IAG-1120
In Commercial Distribution

  • B110IAG11200 ()
IAG-1120

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IA-1112
In Commercial Distribution

  • B110IA11120 ()
IA-1112

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent
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
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