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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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HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309522
In Commercial Distribution

  • 00630414498461 ()
7720961

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV Total - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10322682
In Commercial Distribution

  • 00630414481883 ()
5500077

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10322676
In Commercial Distribution

  • 00630414481876 ()
5498862

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK623.S.A
In Commercial Distribution

  • 05051700017985 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages.
Wallac Oy
3093-001U
In Commercial Distribution

  • 06438147356218 ()
3093-001U

  • Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry
ARCHITECT HAVAB-M Reagent Kit
Abbott GmbH
6L21-25
In Commercial Distribution

  • 00380740011093 ()
06L2125

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT HAVAB-M Controls
Abbott GmbH
6L21-10
In Commercial Distribution

  • 00380740011086 ()
06L2110

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
ARCHITECT HAVAB-M Calibrator
Abbott GmbH
6L21-01
In Commercial Distribution

  • 00380740011079 ()
06L2101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i HAVAb IgM Reagent Kit 1000 Tests
Abbott GmbH
08P2831
In Commercial Distribution

  • 00380740136628 ()
08P2831

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgM Reagent Kit 200 Tests
Abbott GmbH
08P2821
In Commercial Distribution

  • 00380740136611 ()
08P2821

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAVAb IgG II Reagent Kit 200 test
Abbott GmbH
06S9321
In Commercial Distribution

  • 00380740197650 ()
06S9321

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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
Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
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)
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)
Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution

  • 04061841171737 ()
50209

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution

  • 04061841171218 ()
50208

  • Coxsackie A/B virus antigen IVD, reagent
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)
No Description
Bion Enterprises, Ltd.
IBN-2110
In Commercial Distribution

  • B110IBN21100 ()
IBN-2110

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IBG-2120
In Commercial Distribution

  • B110IBG21200 ()
IBG-2120

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
IAN-1110
In Commercial Distribution

  • B110IAN11100 ()
IAN-1110

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IAG-1120
In Commercial Distribution

  • B110IAG11200 ()
IAG-1120

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control
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