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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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Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381336
In Commercial Distribution

  • 00630414961637 ()
L2KHPG2

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX2G060
In Commercial Distribution

  • ENTICOX2G0600 ()
COX2G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX1G060
In Commercial Distribution

  • ENTICOX1G0600 ()
COX1G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
FITC anti-IgG Goat Polyclonal Antibody, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8535-M250
In Commercial Distribution

  • 00615233010575 ()
8535-M250

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8535-C010
In Commercial Distribution

  • 00615233002303 ()
8535-C010

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
QMedix™ EBV VCA IgG ImmunoFlourescent Assay
Diagnostic Automation, Inc.
DACD401010-G
In Commercial Distribution

  • 00850054026613 ()

  • 10, 10-well slides
401010-G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325800
In Commercial Distribution

  • 05391516743570 ()

  • 96 Tests
2325800

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV EA-D IgG
CLARK LABORATORIES, INC.
2325000
In Commercial Distribution

  • 05391516743365 ()

  • 96 Tests
2325000

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBV VCA P-18 IgG
CLARK LABORATORIES, INC.
2324700
In Commercial Distribution

  • 05391516743334 ()

  • 96 Tests
2324700

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ EBNA-1 IgG
CLARK LABORATORIES, INC.
2325801
In Commercial Distribution

  • 05391516747097 ()

  • 480 Tests
2325801

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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