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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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NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgG - ENTICOX1G0600

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)

Histofluor® Rodent LKS Fluorescent Antibody Test System - M749120750211

Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.
IMMUNO CONCEPTS INC
12075-02 (1)
In Commercial Distribution

  • M749120750211 ()
12075-02 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Histofluor® Rodent LKS Fluorescent Antibody Test System - M749120090211

Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 9ml.
IMMUNO CONCEPTS INC
12009-02 (1)
In Commercial Distribution

  • M749120090211 ()
12009-02 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

ANCA Test System - M749100091111

ANCA IgG Fluorescent Antibody Reagent - 1 x 9 mls.
IMMUNO CONCEPTS INC
10009-11 (1)
In Commercial Distribution

  • M749100091111 ()
10009-11 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Echinococcus IgG ELISA Test Kit - B350GSD0130030

Echinococcus IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3003
In Commercial Distribution

  • B350GSD0130030 ()
GSD01-3003

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit - B3507206400

Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit
Gold Standard Diagnostics Corporation
720-640
In Commercial Distribution

  • B3507206400 ()
720-640

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

Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit - B3507206200

Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
720-620
In Commercial Distribution

  • B3507206200 ()
720-620

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

Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit - B3507206000

Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit
Gold Standard Diagnostics Corporation
720-600
In Commercial Distribution

  • B3507206000 ()
720-600

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

EBV-VCA IgG Test System, 120 Tests - B110EBG1200

No Description
Bion Enterprises, Ltd.
EBG-120
In Commercial Distribution

  • B110EBG1200 ()
EBG-120

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

NovaLisa Echinococcus IgG - ENTIECHG01300

The Echinococcus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Echinococcus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ECHG0130
In Commercial Distribution

  • ENTIECHG01300 ()
ECHG0130

  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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