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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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Alinity - 00380740174347

Alinity i Toxo IgG Controls
Abbott GmbH
07P4514
In Commercial Distribution

  • 00380740174347 ()
07P4514

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

Alinity - 00380740131371

Alinity i HAVAb IgG Reagent Kit 200 Tests
Abbott GmbH
08P2721
In Commercial Distribution

  • 00380740131371 ()
08P2721

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

ARCHITECT - 00380740011185

ARCHITECT HAVAB-G Reagent Kit
Abbott GmbH
6L27-25
In Commercial Distribution

  • 00380740011185 ()
06L2725

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

Ureaplasma urealyticum IgG ELISA - 00404847446234

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

  • 00404847446234 ()
EIA-4623

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

Mycoplasma hominis IgG ELISA - 00404847445596

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

  • 00404847445596 ()
EIA-4559

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

Influenza Virus B IgG ELISA - 00404847437966

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
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

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

Mycoplasma pneumoniae IgG ELISA - 00404847434996

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. This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3499
Not in Commercial Distribution

  • 00404847434996 ()
EIA-3499

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

Cornybacterium diphtheriae toxin IgG ELISA - 00404847438246

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
Not in Commercial Distribution

  • 00404847438246 ()
EIA-3824

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

Influenza Virus A IgG ELISA - 00404847437935

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
Not in Commercial Distribution

  • 00404847437935 ()
EIA-3793

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

Diphtheria IgG ELISA - 00404847425147

Enzyme immunoassay for the quantitative determination of IgG class antibodies against Diphtheria in human serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2514
Not in Commercial Distribution

  • 00404847425147 ()
EIA-2514

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

Atellica IM Herpes-2 IgG Quality Control - 00842768022838

Herpes-2 IgG (HSV2) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733034
In Commercial Distribution

  • 00842768022838 ()
10733034

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

Atellica IM Herpes-1 IgG Quality Control - 00842768022791

Herpes-1 IgG (HSV1) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733032
In Commercial Distribution

  • 00842768022791 ()
10733032

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

GAP®-IgG (Gastritis and Peptic Ulcer Test) - 08305900070040

The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
BIOMERICA, INC.
7004
Not in Commercial Distribution

  • 08305900070040 ()


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

VIDAS® H. pylori IgG - 03573026509231

VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA).
BIOMERIEUX SA
30192-01
In Commercial Distribution

  • 03573026509231 ()


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

VIDAS® Varicella-Zoster IgG - 03573026064518

VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.
BIOMERIEUX SA
30217
In Commercial Distribution

  • 03573026064518 ()


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

QUANTA Lite® H.pylori IgG ELISA - 08426950593256

1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708715
In Commercial Distribution

  • 08426950593256 ()


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

BioPlex 2200 - 03610520652787

BioPlex 2200 Syphilis Total & RPR Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
12000652
In Commercial Distribution

  • 03610520652787 ()

  • 1 Each
12000652

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator

BioPlex 2200 - 03610520652770

BioPlex 2200 Syphilis Total & RPR Calibrator Set
BIO-RAD LABORATORIES, INC.
12000651
In Commercial Distribution

  • 03610520652770 ()

  • Total Volume: 0.5 Milliliter
  • 5 Vials
12000651

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator

LIAISON® Control HSV-1 IgG - 08056771600248

No Description
Diasorin Inc.
310831
In Commercial Distribution

  • 08056771600248 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control HSV-2 IgG - 08056771600118

No Description
Diasorin Inc.
310621
In Commercial Distribution

  • 08056771600118 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

LIAISON® MUREX HCV Ab - 08056771500197

No Description
DIASORIN S.P.A.
318240
In Commercial Distribution

  • 08056771500197 ()
  • 18056771500194 ()


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

LIAISON® Control Toxo IgG II - 08056771100779

No Description
DIASORIN SPA
310706
In Commercial Distribution

  • 08056771100779 ()


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

CHORUS INFLUENZA B IgG - 08033891327538

No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

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

CHORUS INFLUENZA A IgG - 08033891327514

No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

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

AccuDiag ™ - 00894175000015

AccuDiag ™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Diagnostic Automation, Inc.
DACD1412-1
In Commercial Distribution

  • 00894175000015 ()

  • 96 tests
1412-1

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

Cornybacterium diphtheriae toxin IgG ELISA - 00840239038241

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 International Inc
EIA-3824
In Commercial Distribution

  • 00840239038241 ()
EIA-3824

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

Influenza Virus B IgG ELISA - 00840239037961

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 International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

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

Influenza Virus A IgG ELISA - 00840239037930

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 International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

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

Mycoplasma pneumoniae IgG ELISA - 00840239034991

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 International Inc
EIA-3499
In Commercial Distribution

  • 00840239034991 ()
EIA-3499

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

H. Pylori IgG ELISA - 00840239028150

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 International Inc
EIA-2815
Not in Commercial Distribution

  • 00840239028150 ()
EIA-2815

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

Varicella Zoster Virus (VZV) IgG ELISA - 00840239028082

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 International Inc
EIA-2808
In Commercial Distribution

  • 00840239028082 ()
EIA-2808

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

Ureaplasma urealyticum IgG ELISA - 00840239046239

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 International Inc
EIA-4623
Not in Commercial Distribution

  • 00840239046239 ()
EIA-4623

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

Mycoplasma hominis IgG ELISA - 00840239045591

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 International Inc
EIA-4559
Not in Commercial Distribution

  • 00840239045591 ()
EIA-4559

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

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) - 04049016059240

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1010 G
Not in Commercial Distribution

  • 04049016059240 ()


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

Anti-RSV IFA (IgG) - 04049016059226

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1003 G
Not in Commercial Distribution

  • 04049016059226 ()


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

Anti-Influenza B Virus ELISA (IgG) - 04049016028345

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution

  • 04049016028345 ()


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

Anti-Influenza A Virus ELISA (IgG) - 04049016028291

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 G
In Commercial Distribution

  • 04049016028291 ()


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

Anti-West Nile Virus ELISA (IgG) - 04049016028178

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2662-9601 G
In Commercial Distribution

  • 04049016028178 ()


  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Mycoplasma pneumoniae ELISA (IgG) - 04049016027652

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2202-9601 G
In Commercial Distribution

  • 04049016027652 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody 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-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

Anti-RSV IFA (IgG) - 04049016059233

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1005 G
Not in Commercial Distribution

  • 04049016059233 ()


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

West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator - 10816101022325

No Description
DIASORIN MOLECULAR LLC
EL0306
In Commercial Distribution

  • 10816101022325 ()
EL0306

  • West Nile virus immunoglobulin G (IgG) antibody IVD, calibrator

HSV-2 ELISA IgG Low Positive Control - 10816101022134

No Description
DIASORIN MOLECULAR LLC
EL0909
In Commercial Distribution

  • 10816101022134 ()
EL0909

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

HSV-2 ELISA IgG High Positive Control - 10816101022127

No Description
DIASORIN MOLECULAR LLC
EL0908
In Commercial Distribution

  • 10816101022127 ()
EL0908

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

HSV-1 ELISA IgG Low Positive Control - 10816101022103

No Description
DIASORIN MOLECULAR LLC
EL0906
In Commercial Distribution

  • 10816101022103 ()
EL0906

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
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