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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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The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. 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 VZV infections. This test is intended for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9331GB
In Commercial Distribution

  • 00845533001281 ()
Q9Z9331GB

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. 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 VZV infections. This test is intended for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9331GB
In Commercial Distribution

  • 00845533001274 ()
9Z9331GB

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. 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 VZV infections. This test is intended for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9331G
In Commercial Distribution

  • 00845533001267 ()
9Z9331G

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
SM3Z17601G
In Commercial Distribution

  • 00845533000925 ()
SM3Z17601G

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
Q3Z17601GB
In Commercial Distribution

  • 00845533000918 ()
Q3Z17601GB

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
3Z17601G
In Commercial Distribution

  • 00845533000901 ()
3Z17601G

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-2010 G
Not in Commercial Distribution

  • 04049016080060 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-2005 G
Not in Commercial Distribution

  • 04049016067849 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1010 G
Not in Commercial Distribution

  • 04049016067832 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1005 G
Not in Commercial Distribution

  • 04049016067825 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-1003 G
Not in Commercial Distribution

  • 04049016067818 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-2005 G
Not in Commercial Distribution

  • 04049016059257 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1010 G
Not in Commercial Distribution

  • 04049016059240 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1005 G
Not in Commercial Distribution

  • 04049016059233 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2670-1003 G
Not in Commercial Distribution

  • 04049016059226 ()


  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution

  • 04049016028345 ()


  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 G
In Commercial Distribution

  • 04049016028291 ()


  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2662-9601 G
In Commercial Distribution

  • 04049016028178 ()


  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2202-9601 G
In Commercial Distribution

  • 04049016027652 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes-2 IgG (HSV2) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733034
In Commercial Distribution

  • 00842768022838 ()
10733034

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
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