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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No Description
CELL MARQUE CORPORATION
367M-18
In Commercial Distribution

  • 00841683112051 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367M-15
In Commercial Distribution

  • 00841683112044 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367M-14
In Commercial Distribution

  • 00841683112037 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367M-16
In Commercial Distribution

  • 00841683112020 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367R-16
In Commercial Distribution

  • 00841683112013 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367R-14
In Commercial Distribution

  • 00841683112006 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367R-15
In Commercial Distribution

  • 00841683111993 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367R-18
In Commercial Distribution

  • 00841683111986 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
367R-17
In Commercial Distribution

  • 00841683111979 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4614
In Commercial Distribution

  • 00841683101307 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
760-2653
In Commercial Distribution

  • 00841683100195 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody
For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903201
In Commercial Distribution

  • G5229032011 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903200
In Commercial Distribution

  • G5229032001 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of measles IgG antibodies in human sera
Hemagen Diagnostics, Inc.
903101
In Commercial Distribution

  • G5229031011 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of measles IgG antibodies in human sera
Hemagen Diagnostics, Inc.
903100
In Commercial Distribution

  • G5229031001 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of rubella virus IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902701
In Commercial Distribution

  • G5229027011 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of rubella virus IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902700
In Commercial Distribution

  • G5229027001 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
VITROS Immunodiagnostic Products Rubella IgG Calibrators
ORTHO CLINICAL DIAGNOSTICS
8209074
In Commercial Distribution

  • 10758750004546 ()
8209074

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Helicobacter Pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB32850 ()
BSB 3285

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
Helicobacter Pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB26830 ()
BSB 2683

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Adenovirus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ADVG0010
In Commercial Distribution

  • ENTIADVG00100 ()
ADVG0010

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Tinto Cathepsin K is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3800-15
In Commercial Distribution

  • B502BSB3800150 ()

  • Total Volume: 15 Milliliter
BSB-3800-15

  • Cathepsin IVD, antibody
No Description
THE BINDING SITE GROUP LIMITED
LK009.10.OPT.A
In Commercial Distribution

  • 05051700021043 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK008.10.OPT.A
In Commercial Distribution

  • 05051700021036 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK007.10.OPT.A
In Commercial Distribution

  • 05051700020930 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK006.10.OPT.A
In Commercial Distribution

  • 05051700020923 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
QMedix™ Measles IgG Enzyme-Linked Immunosorbent 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

  • 00850054026156 ()

  • 96 Tests/Kit
1408-1

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™ Rubella IgG ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1301-1
In Commercial Distribution

  • 00850054026019 ()

  • 96 tests
1301-1

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
RANDOX LABORATORIES LIMITED
IG3896
In Commercial Distribution

  • 05055273203967 ()
IG3896

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
Captia™ Measles IgG
CLARK LABORATORIES, INC.
2326000
In Commercial Distribution

  • 05391516743631 ()

  • 96 Tests
2326000

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Mumps IgG
CLARK LABORATORIES, INC.
2325900
In Commercial Distribution

  • 05391516743600 ()

  • 96 Tests
2325900

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Rubella IgG
CLARK LABORATORIES, INC.
2325300
In Commercial Distribution

  • 05391516743433 ()

  • 96 Tests
2325300

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Cytomegalovirus (CMV) IgG
CLARK LABORATORIES, INC.
2325200
In Commercial Distribution

  • 05391516743402 ()

  • 96 Tests
2325200

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9271GB
In Commercial Distribution

  • 00845533000819 ()
9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
Q9Z9501GB
In Commercial Distribution

  • 00845533000383 ()
Q9Z9501GB

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
SM9Z9501G
In Commercial Distribution

  • 00845533000376 ()
SM9Z9501G

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
9Z9501G
In Commercial Distribution

  • 00845533000369 ()
9Z9501G

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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.
9Z9281G
In Commercial Distribution

  • 00845533000864 ()
9Z9281G

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9271G
In Commercial Distribution

  • 00845533000833 ()
SM9Z9271G

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9271GB
In Commercial Distribution

  • 00845533000826 ()
Q9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9271G
In Commercial Distribution

  • 00845533000802 ()
9Z9271G

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