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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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Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Human-antisera, Pseudomonas-CF-IgG
Ssi Diagnostica A/S
64742
Not in Commercial Distribution

  • 05713106647424 ()
64742

  • Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA070.A
In Commercial Distribution

  • 05051700021005 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA069.A
In Commercial Distribution

  • 05051700020992 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA068.A
In Commercial Distribution

  • 05051700020985 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA115.A
In Commercial Distribution

  • 05051700019583 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, calibrator
Captia™ Varicella-Zoster Virus (VZV) IgG
CLARK LABORATORIES, INC.
2325601
In Commercial Distribution

  • 05391516747066 ()

  • 480 Tests
2325601

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206621
In Commercial Distribution

  • 05391516746359 ()
1206621

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, control
Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
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)
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