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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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Thistle, Russian Salsola kali - 00816879021769

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
W011
Not in Commercial Distribution

  • 00816879021769 ()
74434

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

Lamb's Quarter (Goosefeet) Chenopodium album - 00816879021752

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
W010
Not in Commercial Distribution

  • 00816879021752 ()
74433

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

Plantain, English Plantago lanceolata - 00816879021745

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
W009
Not in Commercial Distribution

  • 00816879021745 ()
74432

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

Mugwort Artemisia vulgaris - 00816879021738

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
W006
Not in Commercial Distribution

  • 00816879021738 ()
74431

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

Ragweed, Common Ambrosia elatior (artemisiifolia) - 00816879021721

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
W001
Not in Commercial Distribution

  • 00816879021721 ()
74430

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

Beech, American Fagus grandifolia (syn. americana) - 00816879021714

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
T005
Not in Commercial Distribution

  • 00816879021714 ()
74429

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

Alder, Smooth Alnus rugosa (serrulata) - 00816879021707

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
T202
Not in Commercial Distribution

  • 00816879021707 ()
74426

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

Olive Tree Olea europaea - 00816879021691

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
T009
Not in Commercial Distribution

  • 00816879021691 ()
74425

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

Oak, Live/Virginia Quercus virginiana - 00816879021684

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
T103
Not in Commercial Distribution

  • 00816879021684 ()
74419

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

Pecan Tree Carya illinoinensis - 00816879021677

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
T022
Not in Commercial Distribution

  • 00816879021677 ()
74415

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