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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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Mumps IgG Test System, 60 Tests - B110MUG600

No Description
Bion Enterprises, Ltd.
MUG-60
Not in Commercial Distribution

  • B110MUG600 ()
MUG-60

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

Mycoplasma pneumoniae IgG Control - B110MPG12200

No Description
Bion Enterprises, Ltd.
MPG-1220
In Commercial Distribution

  • B110MPG12200 ()
MPG-1220

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control

Measles IgG Test System, 120 Tests - B110MEG1200

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

  • B110MEG1200 ()
MEG-120

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

Influenza B Negative Control - B110IBN21100

No Description
Bion Enterprises, Ltd.
IBN-2110
In Commercial Distribution

  • B110IBN21100 ()
IBN-2110

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

Influenza A IgG Control - B110IAG11200

No Description
Bion Enterprises, Ltd.
IAG-1120
In Commercial Distribution

  • B110IAG11200 ()
IAG-1120

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control

EBV IgG Control - B110EBG50200

No Description
Bion Enterprises, Ltd.
EBG-5020
In Commercial Distribution

  • B110EBG50200 ()
EBG-5020

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

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

KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT - B126KR65900

A radioimmunoassay for the quantitative of qualitative determination ofantibodies to the acetylcholine receptor (AChR) in human serum.
KRONUS, INC.
KR6590
In Commercial Distribution

  • B126KR65900 ()
KR6590

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

KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT - B126KR65800

A radioimmunoassay for the quantitative of qualitative determination ofantibodies to the acetylcholine receptor (AChR) in human serum.
KRONUS, INC.
KR6580
In Commercial Distribution

  • B126KR65800 ()
KR6580

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