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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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Aquaporin-4 Auto-Antibody (AQP4Ab) - B126KR82000

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

Zinc Transporter 8 Auto-Antibody (ZnT8) - B126KR77300

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.
KRONUS, INC.
KR7730
In Commercial Distribution

  • B126KR77300 ()
KR7730

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT - B126KR71100

An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
KRONUS, INC.
KR7110
In Commercial Distribution

  • B126KR71100 ()
KR7110

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS 21-OH Autoantibody (21-OH) ELISA Kit - B126KR70150

An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR7015
In Commercial Distribution

  • B126KR70150 ()
KR7015

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

ASI VZV IgG EIA Test - 00816057020584

Detection of Varicella Zoster Antibody
ARLINGTON SCIENTIFIC, INC.
NC-840096-AG
In Commercial Distribution

  • 00816057020584 ()

  • 96 Test
NC-840096-AG

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

OT EQUATOR-OT BRIDGE - D821130CTH4

No Description
RHEIN 83 SRL
OT EQUATOR GL Impl/System C-TECH h.4
Not in Commercial Distribution

  • D821130CTH4 ()
VE057

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Ureaplasma urealyticum IgG ELISA - 04048474046236

The DRG Ureaplasma urealyticum IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Ureaplasma urealyticum in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4623
Not in Commercial Distribution

  • 04048474046236 ()
EIA-4623

  • Ureaplasma urealyticum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Mycoplasma hominis IgG ELISA - 04048474045598

The DRG Mycoplasma hominis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma hominis in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4559
Not in Commercial Distribution

  • 04048474045598 ()
EIA-4559

  • Mycoplasma hominis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Cornybacterium diphtheriae toxin IgG ELISA - 04048474038248

The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative determination of IgG class antibodies against Corynebacterium diphtheriae toxin in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3824
In Commercial Distribution

  • 04048474038248 ()
EIA-3824

  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza Virus B IgG ELISA - 04048474037968

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
In Commercial Distribution

  • 04048474037968 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza Virus A IgG ELISA - 04048474037937

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
In Commercial Distribution

  • 04048474037937 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Mycoplasma pneumoniae IgG ELISA - 04048474034998

The DRG Mycoplasma pneumoniae IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma pneumoniae in human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3499
In Commercial Distribution

  • 04048474034998 ()
EIA-3449

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

H. Pylori IgG ELISA - 04048474028157

The DRG Helicobacter pylori IgG ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2815
Not in Commercial Distribution

  • 04048474028157 ()
EIA-2815

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Varicella Zoster Virus (VZV) IgG ELISA - 04048474028089

The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2808
In Commercial Distribution

  • 04048474028089 ()
EIA-2808

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

Anti-RSV IFA (IgG) - 04049016080060

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-2010 G
Not in Commercial Distribution

  • 04049016080060 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Candida albicans IFA (IgG) - 04049016067849

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-2005 G
Not in Commercial Distribution

  • 04049016067849 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Candida albicans IFA (IgG) - 04049016067832

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1010 G
Not in Commercial Distribution

  • 04049016067832 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Candida albicans IFA (IgG) - 04049016067825

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1005 G
Not in Commercial Distribution

  • 04049016067825 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Candida albicans IFA (IgG) - 04049016067818

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1003 G
Not in Commercial Distribution

  • 04049016067818 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-RSV IFA (IgG) - 04049016059257

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-2005 G
Not in Commercial Distribution

  • 04049016059257 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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