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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 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)
The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Genbio
800-1200
In Commercial Distribution

  • 00613745012001 ()

  • 100 tests
1200

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
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)
No Description
OXOID LIMITED
CT0043B
In Commercial Distribution

  • 05032384005888 ()
  • 05032384502530 ()


  • Penicillin G susceptibility testing disc IVD
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
Toxoplasma G - IgG (ToxG) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995699
In Commercial Distribution

  • 00630414600123 ()
10995699

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381268
In Commercial Distribution

  • 00630414964805 ()
LKTXP1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381323
In Commercial Distribution

  • 00630414962238 ()
L2KTXP2

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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
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