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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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Hevylite® Human IgG Kappa Kit for use on the Siemens BN™II - 05051700012454

No Description
THE BINDING SITE GROUP LIMITED
NK621.T
In Commercial Distribution

  • 05051700012454 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

MININEPH™ Human IgG Kit - 05051700011266

No Description
THE BINDING SITE GROUP LIMITED
ZK004.R
Not in Commercial Distribution

  • 05051700011266 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit - 05051700010443

No Description
THE BINDING SITE GROUP LIMITED
RN004.3
Not in Commercial Distribution

  • 05051700010443 ()


  • Total immunoglobulin G (IgG total) IVD, kit, precipitation/immunodiffusion

Atellica CH IgG_2 - 00630414596266

Immunoglobulin G (IgG_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097616
In Commercial Distribution

  • 00630414596266 ()
11097616

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGG_2 Reagents - 00630414513119

IgG - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309031
In Commercial Distribution

  • 00630414513119 ()
2193432

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgG - 00842768009808

Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446299
In Commercial Distribution

  • 00842768009808 ()
OSAS19

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

N Antisera to Human IgG - 00842768009785

Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446297
In Commercial Distribution

  • 00842768009785 ()
OSAS11

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin G Flex® reagent cartridge - 00842768006180

For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Tinaquant IgG Gen2 - 04015630925735

No Description
Roche Diagnostics GmbH
5220718190
In Commercial Distribution

  • 04015630925735 ()
5220718190

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

IGG Immunoglobulin G Turbidimetric) - 04015630913923

No Description
Roche Diagnostics GmbH
20766631322
In Commercial Distribution

  • 04015630913923 ()
20766631322

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Tinaquant IgG Gen2 - 04015630919710

No Description
Roche Diagnostics GmbH
3507432190
In Commercial Distribution

  • 04015630919710 ()
3507432190

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Tinaquant IgG Gen2 - 04015630919697

No Description
Roche Diagnostics GmbH
3507378190
In Commercial Distribution

  • 04015630919697 ()
3507378190

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006823

VITROS Chemistry Products IgG Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801733
In Commercial Distribution

  • 10758750006823 ()
  • 20758750006820 ()
6801733

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Adenovirus Negative Control - B110ADN31100

No Description
Bion Enterprises, Ltd.
ADN-3110
Not in Commercial Distribution

  • B110ADN31100 ()
ADN-3110

  • Adenovirus immunoglobulin G (IgG) antibody IVD, control

Adenovirus IgG Control - B110ADG31200

No Description
Bion Enterprises, Ltd.
ADG-3120
Not in Commercial Distribution

  • B110ADG31200 ()
ADG-3120

  • Adenovirus immunoglobulin G (IgG) antibody IVD, control

Tina-quant IgG Gen.2 - 07613336121320

No Description
Roche Diagnostics GmbH
08057915190
In Commercial Distribution

  • 07613336121320 ()
08057915190

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Synchron - 15099590231613

Immunoglobulin G Reagent (Ig-G 2 x 150)
Beckman Coulter, Inc.
467925
In Commercial Distribution

  • 15099590231613 ()
467925

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590226985

IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
Beckman Coulter, Inc.
447020
In Commercial Distribution

  • 15099590226985 ()
447020

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590223885

IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
Beckman Coulter, Inc.
446400
In Commercial Distribution

  • 15099590223885 ()
446400

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

AU - 15099590011581

IgG
Beckman Coulter, Inc.
OSR61172
In Commercial Distribution

  • 15099590011581 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

UV Radiation Treatment System - 06921745209029

No Description
Xuzhou Yongkang Electronic Science Technology Co., Ltd
YK-6000B-T
In Commercial Distribution

  • 06921745209029 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control

ZYMUTEST HIA MonoStrip IgG - 03663537046803

No Description
HYPHEN BIOMED
RK041A
In Commercial Distribution

  • 03663537046803 ()
RK041A

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ZYMUTEST HIA IgG - 03663537018763

No Description
HYPHEN BIOMED
RK040A
In Commercial Distribution

  • 03663537018763 ()
RK040A

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

Anti-Adenovirus IFA (IgG) - 04049016059417

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-2005 G
Not in Commercial Distribution

  • 04049016059417 ()


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

Anti-Adenovirus IFA (IgG) - 04049016059400

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1010 G
Not in Commercial Distribution

  • 04049016059400 ()


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

Anti-Adenovirus IFA (IgG) - 04049016059394

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1005 G
Not in Commercial Distribution

  • 04049016059394 ()


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

Anti-Adenovirus IFA (IgG) - 04049016059387

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1003 G
Not in Commercial Distribution

  • 04049016059387 ()


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

Validate - 00850011135518

Rubella IgG Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
802re
In Commercial Distribution

  • 00850011135518 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740180973

Alinity i CMV IgG Controls
Abbott Ireland Diagnostics
07P4212
In Commercial Distribution

  • 00380740180973 ()
07P4212

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

Atellica IM CMV IgG Quality Control - 00630414246482

CMV IgG Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
11202209
In Commercial Distribution

  • 00630414246482 ()
  • 00630414283920 ()
11202209

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