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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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Rabbit Monoclonal Anti-Human IgG4 Antibody, EP138 - 00810113063898

Rabbit Monoclonal Anti-Human IgG4 (138), 1 mL concentrated
Epitomics Inc.
AC-0148
In Commercial Distribution

  • 00810113063898 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Rabbit Monoclonal Anti-Human IgG4 Antibody, EP138 - 00810113063881

Rabbit Monoclonal Anti-Human IgG4 (138), 0.1 mL concentrated
Epitomics Inc.
AC-0148A
In Commercial Distribution

  • 00810113063881 ()

  • Total Volume: 0.1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Rabbit Monoclonal Anti-Human IgG4 Antibody, EP138 - 00810113063874

Rabbit Monoclonal Anti-Human IgG4 (138), 0.5 mL concentrated
Epitomics Inc.
AC-0148B
In Commercial Distribution

  • 00810113063874 ()

  • Total Volume: 0.5 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

ANTI-CATHEPSIN D - 00810119678362

No Description
BIOGENEX LABORATORIES
AM467-5M
In Commercial Distribution

  • 00810119678362 ()

  • Total Volume: 6 Milliliter
AM467-5M

  • Cathepsin IVD, antibody

ANTI-Cathepsin D - 00810119674272

No Description
BIOGENEX LABORATORIES
MU961-5UC
In Commercial Distribution

  • 00810119674272 ()

  • Total Volume: 0.5 Milliliter
MU961-5UC

  • Cathepsin IVD, antibody

Mumps 10 Well; 10 pk - 00813545026059

No Description
SCIMEDX CORPORATION
I-MUV01X
In Commercial Distribution

  • 00813545026059 ()
I-MUV01X

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

Mumps IgG 120 Test Kit - 00813545026035

No Description
SCIMEDX CORPORATION
I-MUV01G
In Commercial Distribution

  • 00813545026035 ()
I-MUV01G

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

Measles 10 Well; 10 pk - 00813545026028

No Description
SCIMEDX CORPORATION
I-MEA01X
In Commercial Distribution

  • 00813545026028 ()
I-MEA01X

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

Measles IgG 120 Test Kit - 00813545026004

No Description
SCIMEDX CORPORATION
I-MEA01G
In Commercial Distribution

  • 00813545026004 ()
I-MEA01G

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

Cytomegalovirus IgG 120 Tests - 00813545025489

No Description
SCIMEDX CORPORATION
I-CMV01G
In Commercial Distribution

  • 00813545025489 ()
I-CMV01G

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

NovaLisa Adenovirus IgG - ENTIADVG00100

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 (BSB-172) - B502BSB3800150

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

AccuDiag ™ - 00850049545686

AccuDiag ™Rubella IgG Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro diagnostic detection and determination of IgG antibody to rubella virus in human sera.
Diagnostic Automation, Inc.
DACD1301-1
In Commercial Distribution

  • 00850049545686 ()

  • 96 tests
1301-1

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

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)

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)

QMedix™ - 00850054026156

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™ - 00850054026019

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)

Optilite® IgG4 Kit (x10) - 05051700021043

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

  • 05051700021043 ()


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

Optilite® IgG3 Kit (x10) - 05051700021036

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

  • 05051700021036 ()


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

Optilite® IgG2 Kit (x10) - 05051700020930

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

  • 05051700020930 ()


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

Optilite® IgG1 Kit (x10) - 05051700020923

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

  • 05051700020923 ()


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

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 IgG2 Kit - 05051700017787

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

  • 05051700017787 ()


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

Optilite IgG1 Kit - 05051700017770

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

  • 05051700017770 ()


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