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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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Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 - 05051700007603

No Description
THE BINDING SITE GROUP LIMITED
NK006.IM
Not in Commercial Distribution

  • 05051700007603 ()


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

Human IgG1 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach - 05051700007597

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

  • 05051700007597 ()


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

Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series - 05051700007566

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

  • 05051700007566 ()


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

Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit - 05051700007559

No Description
THE BINDING SITE GROUP LIMITED
NK006.2TB
In Commercial Distribution

  • 05051700007559 ()


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

Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II Bulk Kit - 05051700007535

No Description
THE BINDING SITE GROUP LIMITED
NK001.T
Not in Commercial Distribution

  • 05051700007535 ()


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

Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II - 05051700006248

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

  • 05051700006248 ()


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

Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 - 05051700006224

No Description
THE BINDING SITE GROUP LIMITED
LK009.IM
Not in Commercial Distribution

  • 05051700006224 ()


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

Hu IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Modular P - 05051700006217

Human IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitachi Modular P
THE BINDING SITE GROUP LIMITED
LK009.H
In Commercial Distribution

  • 05051700006217 ()


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

Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series - 05051700006187

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

  • 05051700006187 ()


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

Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - 05051700006170

Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - Bulk Kit
THE BINDING SITE GROUP LIMITED
LK009.2TB
In Commercial Distribution

  • 05051700006170 ()


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

Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - 05051700006163

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

  • 05051700006163 ()


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

Beckman Immage IgG3 Latex Kit - 05051700006149

No Description
THE BINDING SITE GROUP LIMITED
LK008.IM
Not in Commercial Distribution

  • 05051700006149 ()


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

Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular P - 05051700006132

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

  • 05051700006132 ()


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

Olympus IgG3 Kit - 05051700006118

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

  • 05051700006118 ()


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

Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit - 05051700006101

No Description
THE BINDING SITE GROUP LIMITED
LK008.2TB
In Commercial Distribution

  • 05051700006101 ()


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

Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - 05051700006088

No Description
THE BINDING SITE GROUP LIMITED
LK001.TB
Not in Commercial Distribution

  • 05051700006088 ()


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

Hu IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Modular P - 05051700006064

Human IgG Subclass Liquid Reagent Kits for use on Hitachi 911/912/917 and Hitachi Modular P
THE BINDING SITE GROUP LIMITED
LK001.H
In Commercial Distribution

  • 05051700006064 ()


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

Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit - 05051700006033

No Description
THE BINDING SITE GROUP LIMITED
LK001.2TB
Not in Commercial Distribution

  • 05051700006033 ()


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

IgG - 05055273203967

No Description
RANDOX LABORATORIES LIMITED
IG3896
In Commercial Distribution

  • 05055273203967 ()
IG3896

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

Trinity Biotech - 05391516747127

Captia™ Measles IgG
CLARK LABORATORIES, INC.
2326001
In Commercial Distribution

  • 05391516747127 ()

  • 480 Tests
2326001

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

Trinity Biotech - 05391516747110

Captia™ Mumps IgG
CLARK LABORATORIES, INC.
2325901
In Commercial Distribution

  • 05391516747110 ()

  • 480 Tests
2325901

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

Trinity Biotech - 05391516747004

Captia™ Rubella IgG
CLARK LABORATORIES, INC.
2325301
In Commercial Distribution

  • 05391516747004 ()

  • 480 Tests
2325301

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

Trinity Biotech - 05391516746984

Captia™ Cytomegalovirus (CMV) IgG
CLARK LABORATORIES, INC.
2325201
In Commercial Distribution

  • 05391516746984 ()

  • 480 Tests
2325201

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

Trinity Biotech - 05391516743631

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)

Trinity Biotech - 05391516743600

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)

Trinity Biotech - 05391516743433

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)

Trinity Biotech - 05391516743402

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)

SeraQuest - 00850487007579

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MUMPS G
In Commercial Distribution

  • 00850487007579 ()
Q01-200

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

SeraQuest - 00850487007388

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
RUB G
In Commercial Distribution

  • 00850487007388 ()
Q01-100

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

SeraQuest - 00850487007357

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MEAS G
In Commercial Distribution

  • 00850487007357 ()
Q01-190

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