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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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Manual & CDs, BioPlex 2200, EBV IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002127 ()

  • 1 Each
6651260E

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
EBV IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651250
In Commercial Distribution

  • 00847865000161 ()

  • 100 Tests
6651250

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H.pylori G
In Commercial Distribution

  • 00850487007531 ()
01550Q-1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H.pylori G
In Commercial Distribution

  • 00850487007159 ()
01550Q-1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia H. pylori IgG
CLARK LABORATORIES, INC.
2346401
In Commercial Distribution

  • 05391516747516 ()

  • 480 Tests
2346401

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia Mycoplasma IgG
CLARK LABORATORIES, INC.
2344800
In Commercial Distribution

  • 05391516743945 ()

  • 96 Tests
2344800

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ H. pylori IgG
CLARK LABORATORIES, INC.
2346400
In Commercial Distribution

  • 05391516743679 ()

  • 96 Tests
2346400

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Ureaplasma urealyticum IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Ureaplasma urealyticum in serum and plasma.
DRG International Inc
EIA-4623
Not in Commercial Distribution

  • 00840239046239 ()
EIA-4623

  • Ureaplasma urealyticum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Mycoplasma pneumoniae IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma pneumoniae in human serum or plasma.
DRG International Inc
EIA-3499
In Commercial Distribution

  • 00840239034991 ()
EIA-3499

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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