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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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Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) - 23661562495584

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
DIAGAST
B49558
In Commercial Distribution

  • 23661562495584 ()
B49558

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Beckman Coulter® PK® Systems Anti-E (906) - 23661562173079

Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17307
In Commercial Distribution

  • 23661562173079 ()
17307

  • Anti-E [RH003] red blood cell grouping IVD, antibody

Lyphochek - 00847661005728

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

Lyphochek - 00847661005759

Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005742

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 - 00847661005735

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

IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM - 00630414979519

Allergen Specific IgE CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388502
In Commercial Distribution

  • 00630414979519 ()
L2UNCVM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control - 00630414984599

Specific IgE Neg - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485107
In Commercial Distribution

  • 00630414984599 ()
L2SNCCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 - 00630414984582

Specific IgE M6 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485106
In Commercial Distribution

  • 00630414984582 ()
MC6LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 - 00630414984575

Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
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