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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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Optilite Hevylite IgG Kappa Kit - 05051700020114

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

  • 05051700020114 ()


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

Optilite IgG CSF Kit - 05051700019835

No Description
THE BINDING SITE GROUP LIMITED
NK004.L.OPT.A
In Commercial Distribution

  • 05051700019835 ()


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

Hevylite Human IgG Lambda Kit for use on the SPAPLUS - 05051700019385

No Description
THE BINDING SITE GROUP LIMITED
NK622.S.A
In Commercial Distribution

  • 05051700019385 ()


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

Hevylite Human IgG Kappa Kit for use on the SPAPLUS - 05051700019378

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

  • 05051700019378 ()


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

Optilite IgG Kit - 05051700017534

No Description
THE BINDING SITE GROUP LIMITED
NK004.OPT.A
In Commercial Distribution

  • 05051700017534 ()


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

Hevylite IgG Lambda Kit for Siemens BNII - 05051700016988

No Description
THE BINDING SITE GROUP LIMITED
NK622.T.A
In Commercial Distribution

  • 05051700016988 ()


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

Hevylite IgG Kappa Kit for Siemens BNII - 05051700016971

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

  • 05051700016971 ()


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

Human IgG CSF Kit for use on SPAPLUS - 05051700016186

No Description
THE BINDING SITE GROUP LIMITED
NK004.L.S
In Commercial Distribution

  • 05051700016186 ()


  • 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

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

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

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

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

AU - 15099590011581

IgG
Beckman Coulter, Inc.
OSR61172
In Commercial Distribution

  • 15099590011581 ()


  • 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

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

PreciControl Rubella IgG - 04015630939268

No Description
Roche Diagnostics GmbH
4618807160
In Commercial Distribution

  • 04015630939268 ()
4618807160

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

PreciControl CMV IgG - 04015630934539

No Description
Roche Diagnostics GmbH
4784600160
In Commercial Distribution

  • 04015630934539 ()
4784600160

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

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) - 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

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) - 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

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)

LIAISON® CMV IgG Serum Control Set - 08056771601863

No Description
DIASORIN SPA
310742
Not in Commercial Distribution

  • 08056771601863 ()


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

LIAISON® Biotrin Control Parvovirus B19 IgG Plus - 08056771104036

Italy manufactured kit.
DIASORIN SPA
311551
In Commercial Distribution

  • 08056771104036 ()


  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control

LIAISON® CMV IgG Serum Control Set - 08056771102933

No Description
DIASORIN SPA
310742
In Commercial Distribution

  • 08056771102933 ()


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

LIAISON® Control CMV IgG - 08056771101912

No Description
DIASORIN SPA
310741
In Commercial Distribution

  • 08056771101912 ()


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

LIAISON® Control Mumps IgG - 08056771101394

No Description
DIASORIN SPA
318841
In Commercial Distribution

  • 08056771101394 ()


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

LIAISON® Control Measles IgG - 08056771101332

No Description
DIASORIN SPA
318811
In Commercial Distribution

  • 08056771101332 ()


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

LIAISON® Rubella IgG TRI-Controls - 08056771100588

No Description
DIASORIN SPA
310461
In Commercial Distribution

  • 08056771100588 ()


  • 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

ADVIA Centaur® Systems HBeAg QC - 00630414531298

Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® Rub G QC - 00630414201429

Rubella IgG - CENTAUR - CONS - 3x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310284
In Commercial Distribution

  • 00630414201429 ()
117711

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