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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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Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000143
In Commercial Distribution

  • 00847661005742 ()
12000143

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000142
In Commercial Distribution

  • 00847661005735 ()
12000142

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000141
In Commercial Distribution

  • 00847661005728 ()
12000141

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
VIROTROL HAV-IgM (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00142A
In Commercial Distribution

  • 00847661005704 ()
00142A

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27125X
In Commercial Distribution

  • 00847661005681 ()
27125X

  • Multiple clinical chemistry protein IVD, control
Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27126
In Commercial Distribution

  • 00847661005674 ()
27126

  • Multiple clinical chemistry protein IVD, control
Lyphochek Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27125
In Commercial Distribution

  • 00847661005667 ()
27125

  • Multiple clinical chemistry protein IVD, control
Lyphochek Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
27124
In Commercial Distribution

  • 00847661005650 ()
27124

  • Multiple clinical chemistry protein IVD, control
Lyphochek Whole Blood Immunosuppressant Control MiniPak (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
279X
In Commercial Distribution

  • 00847661005636 ()
279X

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128B
In Commercial Distribution

  • 00847661005575 ()
00128B

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
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