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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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Total IgE Sample Diluent - 00816879022223

No Description
HYCOR BIOMEDICAL LLC
309046
Not in Commercial Distribution

  • 00816879022223 ()


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

MCS Specific/Total IgE Conjugate - 00816879022216

No Description
HYCOR BIOMEDICAL LLC
308174
Not in Commercial Distribution

  • 00816879022216 ()
308174

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

EIA Wash Solution - 00816879022148

No Description
HYCOR BIOMEDICAL LLC
308126
Not in Commercial Distribution

  • 00816879022148 ()


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

Stop Solution (Allergy) - 00816879022131

No Description
HYCOR BIOMEDICAL LLC
308151
Not in Commercial Distribution

  • 00816879022131 ()
308151

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

IgE Reference Discs - 00816879022070

No Description
HYCOR BIOMEDICAL LLC
74112
Not in Commercial Distribution

  • 00816879022070 ()
74112

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

Pine, Ponderosa Pinus ponderosa - 00816879022049

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
T042
Not in Commercial Distribution

  • 00816879022049 ()
749720

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

IMMULITE®2000 Systems 3gAllergy™ Baccharis halimifolia - 00630414979212

Baccharis -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386159
In Commercial Distribution

  • 00630414979212 ()
W67L2

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

IMMULITE®2000 Systems 3gAllergy™ Dog Fennel - 00630414979205

Dog Fennel-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386156
In Commercial Distribution

  • 00630414979205 ()
W46L2

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

IMMULITE®2000 Systems 3gAllergy™ Common Sagebrush - 00630414979199

Common Sagebrush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386155
In Commercial Distribution

  • 00630414979199 ()
W43L2

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

IMMULITE®2000 Systems 3gAllergy™ Saltbush - 00630414979182

Saltbush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386153
In Commercial Distribution

  • 00630414979182 ()
W37L2

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