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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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ST AIA-PACK IgEII - 14560189210155

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210155 ()
  • 04560189210158 ()


  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

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

IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 - 00630414984568

Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

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

NOVEOS IgE Positive Control Pack - 00816879029543

No Description
HYCOR BIOMEDICAL LLC
63150Z
In Commercial Distribution

  • 00816879029543 ()


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

NOVEOS IgE Negative Control Pack - 00816879029536

No Description
HYCOR BIOMEDICAL LLC
63155Z
In Commercial Distribution

  • 00816879029536 ()


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

NOVEOS IgE Negative Control Pack - 00816879023039

No Description
HYCOR BIOMEDICAL LLC
63155
In Commercial Distribution

  • 00816879023039 ()


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

NOVEOS IgE Positive Control Pack - 00816879023022

No Description
HYCOR BIOMEDICAL LLC
63150
In Commercial Distribution

  • 00816879023022 ()


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

SPECIFIC IGE CONTROL KIT - 00816879022063

No Description
HYCOR BIOMEDICAL LLC
71207
Not in Commercial Distribution

  • 00816879022063 ()


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