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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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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

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

Atellica IM Rub G QC - 00630414600536

Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995671
In Commercial Distribution

  • 00630414600536 ()
10995671

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

Atellica™ IM HBeAg QC - 00630414599229

Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995599
In Commercial Distribution

  • 00630414599229 ()
10995599

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

ADVIA Centaur CMV IgG QC - 00630414587448

CMV IgG ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10630613
In Commercial Distribution

  • 00630414587448 ()
  • 00630414224138 ()
10630613

  • Cytomegalovirus (CMV) 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

IMMULITE® Systems RUB CONTROL Rubella IgG - 00630414976730

Rubella IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469599
In Commercial Distribution

  • 00630414976730 ()
LRUBCM

  • Rubella virus 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

IMMULITE Systems Rubella Quantitative IgG CVM - 00630414973784

Rubella Quantitative IgG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388114
In Commercial Distribution

  • 00630414973784 ()
LRUBCVM

  • Rubella virus 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

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

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
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