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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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AccuDiag ™ - 00850049545396

AccuDiag ™Measles IgG Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibodies to Measles (Rubeola) virus in human sera.
Diagnostic Automation, Inc.
DACD1408-1
In Commercial Distribution

  • 00850049545396 ()

  • 96 tests
1408-1

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IgG - 05055273203967

No Description
RANDOX LABORATORIES LIMITED
IG3896
In Commercial Distribution

  • 05055273203967 ()
IG3896

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ZEUS ELISA Parvovirus B19 IgG Test System - 00845533001748

The ZEUS ELISA Parvovirus B19 IgG Test System is intended for the qualitative detection of IgG class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is intended for in vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
SM9Z7701G
In Commercial Distribution

  • 00845533001748 ()
SM9Z7701G

  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ZEUS ELISA Parvovirus B19 IgG Test System - 00845533001731

The ZEUS ELISA Parvovirus B19 IgG Test System is intended for the qualitative detection of IgG class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is intended for in vitro diagnostic use only
ZEUS SCIENTIFIC, INC.
9Z7701GB
In Commercial Distribution

  • 00845533001731 ()
9Z7701GB

  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ZEUS ELISA Parvovirus B19 IgG Test System - 00845533001724

The ZEUS ELISA Parvovirus B19 IgG Test System is intended for the qualitative detection of IgG class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is intended for in vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
9Z7701G
In Commercial Distribution

  • 00845533001724 ()
9Z7701G

  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IFA VZV IgG Test System - 00845533001649

The ZEUS IFA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative and semi-quantitative detection of VZ IgG antibody in human sera by the indirect fluorescent antibody (IFA) technique. The assay can determine or confirm a recent infection or immune status, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9301
In Commercial Distribution

  • 00845533001649 ()
FA9301

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ELISA Rubella IgG Smart Kit Test System - 00845533001021

The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9801G
In Commercial Distribution

  • 00845533001021 ()
SM9Z9801G

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Rubella IgG Q Test System - 00845533001014

The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9801GB
In Commercial Distribution

  • 00845533001014 ()
Q9Z9801GB

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Rubella IgG Bulk Test System - 00845533001007

The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9801GB
In Commercial Distribution

  • 00845533001007 ()
9Z9801GB

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Rubella IgG Test System - 00845533000994

The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9801G
In Commercial Distribution

  • 00845533000994 ()
9Z9801G

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Mumps IgG Smart Kit Test System - 00845533000895

The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. 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 Mumps infections.
ZEUS SCIENTIFIC, INC.
SM9Z9281G
In Commercial Distribution

  • 00845533000895 ()
SM9Z9281G

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Mumps IgG Q Test System - 00845533000888

The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. 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 Mumps infections.
ZEUS SCIENTIFIC, INC.
Q9Z9281GB
In Commercial Distribution

  • 00845533000888 ()
Q9Z9281GB

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Mumps IgG Bulk Test System - 00845533000871

The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. 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 Mumps infections.
ZEUS SCIENTIFIC, INC.
9Z9281GB
In Commercial Distribution

  • 00845533000871 ()
9Z9281GB

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Alinity - 00380740153922

Alinity c Immunoglobulin G Reagent Kit 360 Tests
Abbott GmbH
09P6220
In Commercial Distribution

  • 00380740153922 ()
09P6220

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740019761

Immunoglobulin G
ABBOTT LABORATORIES
9D99-21
In Commercial Distribution

  • 00380740019761 ()
09D9921

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740011178

ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

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

Alinity - 00380740197643

HAVAb IgG II Controls
Abbott GmbH
06S9310
In Commercial Distribution

  • 00380740197643 ()
06S9310

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

Alinity - 00380740180966

Alinity i CMV IgG Calibrators
Abbott Ireland Diagnostics
07P4202
In Commercial Distribution

  • 00380740180966 ()
07P4202

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740175184

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

  • 00380740175184 ()
09D9922

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740169909

Immunoglobulin G 388 tests
ABBOTT IRELAND
09D9924
In Commercial Distribution

  • 00380740169909 ()
09D9924

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Alinity - 00380740169893

Immunoglobulin G 360 Tests
ABBOTT IRELAND
09P6224
In Commercial Distribution

  • 00380740169893 ()
09P6224

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Dimension® Flex® reagent cartridge IGG - 00842768005701

Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Bio-Rad Laboratories - 00847865010771

Mumps IgG EIA
Bio-RAD Laboratories, Inc.
25182
In Commercial Distribution

  • 00847865010771 ()

  • 96 Tests
25182

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Laboratories - 00847865010764

Measles IgG EIA
Bio-RAD Laboratories, Inc.
25181
In Commercial Distribution

  • 00847865010764 ()

  • 96 Tests
25181

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Laboratories, Inc. - 00847865010726

CMV IgG EIA
Bio-RAD Laboratories, Inc.
25177
In Commercial Distribution

  • 00847865010726 ()

  • 96 Tests
25177

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Laboratories, Inc. - 00847865010689

Rubella IgG EIA
Bio-RAD Laboratories, Inc.
25173
In Commercial Distribution

  • 00847865010689 ()

  • 96 Tests
25173

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Human IgG4 SPA PLUS Bulk Kit - 05051700017978

No Description
THE BINDING SITE GROUP LIMITED
LK009.10S.A
In Commercial Distribution

  • 05051700017978 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG3 SPA PLUS Bulk Kit - 05051700017961

No Description
THE BINDING SITE GROUP LIMITED
LK008.10S.A
In Commercial Distribution

  • 05051700017961 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG2 SPA PLUS Bulk Kit - 05051700017954

No Description
THE BINDING SITE GROUP LIMITED
NK007.10S.A
In Commercial Distribution

  • 05051700017954 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG1 SPA PLUS Bulk Kit - 05051700017947

No Description
THE BINDING SITE GROUP LIMITED
NK006.10S.A
In Commercial Distribution

  • 05051700017947 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgG4 Kit - 05051700017558

No Description
THE BINDING SITE GROUP LIMITED
LK009.OPT.A
In Commercial Distribution

  • 05051700017558 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgG3 - 05051700017541

No Description
THE BINDING SITE GROUP LIMITED
LK008.OPT.A
In Commercial Distribution

  • 05051700017541 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG4 Subclass Liquid Reagent Kit for use on the SPAPLUS- Bulk Kit - 05051700016407

No Description
THE BINDING SITE GROUP LIMITED
LK009.10S
In Commercial Distribution

  • 05051700016407 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG3 Subclass Liquid Reagent Kit for use on the SPAPLUS- Bulk Kit - 05051700016391

No Description
THE BINDING SITE GROUP LIMITED
LK008.10S
In Commercial Distribution

  • 05051700016391 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG2 SPA PLUS Bulk Kit - 05051700016384

No Description
THE BINDING SITE GROUP LIMITED
NK007.10S
In Commercial Distribution

  • 05051700016384 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Human IgG1 Subclass Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit - 05051700016377

No Description
THE BINDING SITE GROUP LIMITED
NK006.10S
In Commercial Distribution

  • 05051700016377 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

IgG SC AMR Set - 05051700015998

No Description
THE BINDING SITE GROUP LIMITED
BP504
In Commercial Distribution

  • 05051700015998 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

MININEPH Human IgG4 Kit - 05051700011303

No Description
THE BINDING SITE GROUP LIMITED
ZK009.L.R
Not in Commercial Distribution

  • 05051700011303 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

MININEPH Human IgG3 Kit - 05051700011297

No Description
THE BINDING SITE GROUP LIMITED
ZK008.L.R
Not in Commercial Distribution

  • 05051700011297 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

MININEPH Human IgG2 Kit - 05051700011280

No Description
THE BINDING SITE GROUP LIMITED
ZK007.R
Not in Commercial Distribution

  • 05051700011280 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
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