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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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ACCURUN® - 00816784020413

ACCURUN 140 Rubella IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0084
In Commercial Distribution

  • 00816784020413 ()
2015-0084

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

Drew Scientific - 00817274020135

Gold Kit 80-100 Test
DREW SCIENTIFIC, INC.
014-080
In Commercial Distribution

  • 00817274020135 ()


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

Mumps IgG Control - B110MUG80200

No Description
Bion Enterprises, Ltd.
MUG-8020
In Commercial Distribution

  • B110MUG80200 ()
MUG-8020

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

CMV IgG Control - B110CMG20200

No Description
Bion Enterprises, Ltd.
CMG-2020
In Commercial Distribution

  • B110CMG20200 ()
CMG-2020

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

Measles IgG Control - B110MEG60200

No Description
Bion Enterprises, Ltd.
MEG-6020
In Commercial Distribution

  • B110MEG60200 ()
MEG-6020

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

PreciControl Anti-CMV - 07613336183151

No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

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

PreciControl Release Anti-CMV - 07613336182987

No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

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

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
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