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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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Atellica IM Rub G - 00630414600529

Rubella IgG (Rub G) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995670
In Commercial Distribution

  • 00630414600529 ()
10995670

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

Elecsys Anti-CMV - 07613336183069

No Description
Roche Diagnostics GmbH
09118551162
In Commercial Distribution

  • 07613336228449 ()
  • 07613336183069 ()
09118551162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay

CMV IgG Test System, 120 Tests - B110CMG1200

No Description
Bion Enterprises, Ltd.
CMG-120
In Commercial Distribution

  • B110CMG1200 ()
CMG-120

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

Borrelia IgG Control - B110BBG61200

No Description
Bion Enterprises, Ltd.
BBG-6120
In Commercial Distribution

  • B110BBG61200 ()
BBG-6120

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

Varicella Zoster IgG Control - B110VZG70200

No Description
Bion Enterprises, Ltd.
VZG-7020
In Commercial Distribution

  • B110VZG70200 ()
VZG-7020

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

Elecsys CMV IgG - 07613336198469

No Description
Roche Diagnostics GmbH
09118551190
In Commercial Distribution

  • 07613336198469 ()
09118551190

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

Elecsys CMV IgG - 07613336193082

No Description
Roche Diagnostics GmbH
09338977160
In Commercial Distribution

  • 07613336193082 ()
09338977160

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

Cytomegalovirus IgG 120 Tests - 00813545025489

No Description
SCIMEDX CORPORATION
I-CMV01G
In Commercial Distribution

  • 00813545025489 ()
I-CMV01G

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

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAb) RIA ASSAY KIT - B126KR75900

A radioimmunoassay for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor (AChR) in human serum.
KRONUS, INC.
KR7590
In Commercial Distribution

  • B126KR75900 ()
KR7590

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT - B126KR67550

A radioimmunoassay for the semi-quantitative determination of antibodies to tyrosine phosphatase (IA-2) in human serum.
KRONUS, INC.
KR6755
In Commercial Distribution

  • B126KR67550 ()
KR6755

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay
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