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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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No Description
DIASORIN MOLECULAR LLC
EL0909
In Commercial Distribution

  • 10816101022134 ()
EL0909

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0905
In Commercial Distribution

  • 10816101022097 ()
EL0905

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0306
In Commercial Distribution

  • 10816101022325 ()
EL0306

  • West Nile virus immunoglobulin G (IgG) antibody IVD, calibrator
No Description
DIASORIN MOLECULAR LLC
EL0908
In Commercial Distribution

  • 10816101022127 ()
EL0908

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0906
In Commercial Distribution

  • 10816101022103 ()
EL0906

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
No Description
Roche Diagnostics GmbH
4618823160
In Commercial Distribution

  • 04015630939343 ()
4618823160

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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)
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)
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)
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)
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)
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)
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)
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)
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)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

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

  • 00083059070040 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
No Description
Diasorin Inc.
310831
In Commercial Distribution

  • 08056771600248 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
No Description
Diasorin Inc.
310621
In Commercial Distribution

  • 08056771600118 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN S.P.A.
318240
In Commercial Distribution

  • 08056771500197 ()
  • 18056771500194 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
310706
In Commercial Distribution

  • 08056771100779 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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)
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-1000
In Commercial Distribution

  • B350GSD0110000 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection.
Gold Standard Diagnostics Corporation
720-380
In Commercial Distribution

  • B3507203800 ()
720-380

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ACCURUN 190 Anti - Trypanosoma cruzi 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0097
In Commercial Distribution

  • 00816784020499 ()
2015-0097

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, control
ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0082
In Commercial Distribution

  • 00816784020390 ()
2015-0082

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
No Description
MONOBIND, INC.
1425-300
In Commercial Distribution

  • 00816870021102 ()

  • Width: 7.75 Inch
1425-300A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-650 EBV-EA-D IgM Test Kit"
DIAMEDIX CORPORATION
720-650
In Commercial Distribution

  • 00817273020365 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-620 EBNA-1 IgG Test Kit"
DIAMEDIX CORPORATION
720-620
In Commercial Distribution

  • 00817273020334 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-600 EBV-VCA IgG Test Kit"
DIAMEDIX CORPORATION
720-600
In Commercial Distribution

  • 00817273020310 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
SCIMEDX CORPORATION
I-RSV01X
In Commercial Distribution

  • 00813545026134 ()
I-RSV01X

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-RSV01G
In Commercial Distribution

  • 00813545026127 ()
I-RSV01G

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