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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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Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720846
In Commercial Distribution

  • 00630414016740 ()
10720846

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310321
In Commercial Distribution

  • 00630414208459 ()
120154

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgG
BIO-RAD LABORATORIES, INC.
425-2340
In Commercial Distribution

  • 00847817018541 ()

  • 96 Tests
4252340

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
HSV-1 IgG Reagent Kit 200 Tests
Abbott Ireland Diagnostics
04W2027
In Commercial Distribution

  • 00380740197704 ()
04W2027

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
HAVAb IgG II Calibrator
Abbott GmbH
06S9301
In Commercial Distribution

  • 00380740197636 ()
06S9301

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i Toxo IgG Reagent Kit (1000T)
Abbott GmbH
07P4545
In Commercial Distribution

  • 00380740174361 ()
07P4545

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Alinity i Toxo IgG Reagent Kit (200T)
Abbott GmbH
07P4540
In Commercial Distribution

  • 00380740174354 ()
07P4540

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
7508US
In Commercial Distribution

  • 04250289503150 ()
7508US

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7508US
In Commercial Distribution

  • 04250289502900 ()
30-7508US

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease.
Aesku.Diagnostics GmbH & Co. KG
3508
In Commercial Distribution

  • 04250289501538 ()


  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
IMMUCOR, INC.
0066828
In Commercial Distribution

  • 10888234001508 ()
0066828

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
Alinity i HAVAb IgG Calibrator
Abbott GmbH
08P2701
In Commercial Distribution

  • 00380740131357 ()
08P2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
ARCHITECT HAVAB-G Calibrator
Abbott GmbH
6L27-01
In Commercial Distribution

  • 00380740011161 ()
06L2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6129
Not in Commercial Distribution

  • 00404847461299 ()
EIA-6129

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum. This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3507
Not in Commercial Distribution

  • 00404847435078 ()
EIA-3507

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Enzyme immunassay for the qualitative and quantitative determination of IgG antibodies against Aspergillus fumigatus in human serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2501
Not in Commercial Distribution

  • 00404847425017 ()
EIA-2501

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes-2 IgG (HSV2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733033
In Commercial Distribution

  • 00842768022807 ()
10733033

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-1 IgG (HSV1) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733031
In Commercial Distribution

  • 00842768022784 ()
10733031

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA 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.
708865
In Commercial Distribution

  • 08426950514206 ()


  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44208
In Commercial Distribution

  • 10680651442083 ()
CRI-17-100-4

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44207
In Commercial Distribution

  • 10680651442076 ()
CRI-17-75-5.5

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
No Description
Diasorin Inc.
310830
In Commercial Distribution

  • 08056771600231 ()
  • 18056771600238 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
310705
In Commercial Distribution

  • 08056771100762 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
DIESSE DIAGNOSTICA SENESE SPA
81036
In Commercial Distribution

  • 08033891327668 ()
81036

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum.
DRG International Inc
EIA-3057
In Commercial Distribution

  • 00840239035073 ()
EIA-3057

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.
DRG International Inc
EIA-3458
In Commercial Distribution

  • 00840239034588 ()

  • Stop Solution
  • Total Volume: 30 Milliliter
  • Wash Solution
  • Enzyme Conjugate
  • Sample Diluent
  • Total Volume: 14 Milliliter
  • Total Volume: 20 Milliliter
  • Substrate Solution
  • Positive Control
  • Negative Control
  • Cut-off Control
  • Total Volume: 2 Milliliter
  • Total Volume: 100 Milliliter
EIA-3458

  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-6129
In Commercial Distribution

  • 00840239061294 ()
EIA-6129

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
COOLIEF* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
CRI-17-150-6
In Commercial Distribution

  • 10193493442109 ()
  • 00193493442102 ()
CRI-17-150-6

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
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