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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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TrinityBiotech - 05391516746342

Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

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

Trinity Biotech - 05391516743945

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)

Trinity Biotech - 05391516743679

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)

Trinity Biotech - 05391516743525

Captia™ Varicella-Zoster Virus (VZV) IgG
CLARK LABORATORIES, INC.
2325600
In Commercial Distribution

  • 05391516743525 ()

  • 96 Tests
2325600

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007340

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
VZV G
In Commercial Distribution

  • 00850487007340 ()
Q01-180

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007531

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)

ReQuest - 00850487007159

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)

ReQuest - 00850487007012

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
VZV G
In Commercial Distribution

  • 00850487007012 ()
Q01-180

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Pseudomonas-CF-IgG kit, ELISA - 05713106647424

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)

ImmunoFA Toxoplasma IgG High Control - 00613745012056

Positive control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1205
In Commercial Distribution

  • 00613745012056 ()

  • 1.0 mL
1205

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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