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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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Immunoglobulin G
Abbott GmbH
9D99-22
Not in Commercial Distribution

  • 00380740175184 ()
09D9922

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin G 388 tests
ABBOTT IRELAND
09D9924
In Commercial Distribution

  • 00380740169909 ()
09D9924

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin G 360 Tests
ABBOTT IRELAND
09P6224
In Commercial Distribution

  • 00380740169893 ()
09P6224

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902801
In Commercial Distribution

  • G5229028011 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902800
In Commercial Distribution

  • G5229028001 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
34430
In Commercial Distribution

  • 15099590624897 ()
34430

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
33435
In Commercial Distribution

  • 15099590624880 ()
34435

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay.
Beckman Coulter, Inc.
34439
In Commercial Distribution

  • 15099590624873 ()
34439

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Immunoglobulin M Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444984
In Commercial Distribution

  • 00842768005732 ()
  • 00630414004600 ()
DF81

  • Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry
Immunoglobulin A Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444982
In Commercial Distribution

  • 00842768005688 ()
  • 00630414004587 ()
DF74

  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
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