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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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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)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007371 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007180 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Alkaline Phosphatase Developing Solution, 110mL
MARDX DIAGNOSTICS, INC.
44-5017
In Commercial Distribution

  • 05391516747707 ()
44-5017

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
10x Sample Diluent/Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-2019C
In Commercial Distribution

  • 05391516747653 ()
40-2019C

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346581
In Commercial Distribution

  • 05391516747486 ()

  • 480 Tests
2346581

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346580
In Commercial Distribution

  • 05391516747189 ()

  • 96 tests
2346580

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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)
Captia™ EBV VCA IgG
CLARK LABORATORIES, INC.
2325700
In Commercial Distribution

  • 05391516747073 ()

  • 96 Tests
2325700

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