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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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Timothy Grass Phleum pratense - 00816879021424

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
G006
Not in Commercial Distribution

  • 00816879021424 ()
74328

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

Rye Grass, Perennial Lolium perenne - 00816879021417

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
G005
Not in Commercial Distribution

  • 00816879021417 ()
74327

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

Bermuda Grass Cynodon dactylon - 00816879021400

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
G002
Not in Commercial Distribution

  • 00816879021400 ()
74326

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

Red Top - 00816879021394

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
G009
Not in Commercial Distribution

  • 00816879021394 ()
74323

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

Crab - 00816879021387

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
F023
Not in Commercial Distribution

  • 00816879021387 ()
74304

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

Brazil Nut - 00816879021370

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
F018
Not in Commercial Distribution

  • 00816879021370 ()
74295

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

Sesame Seed (Bruised Grain) - 00816879021363

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
F010
Not in Commercial Distribution

  • 00816879021363 ()
74293

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

Rye - 00816879021356

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
F005
Not in Commercial Distribution

  • 00816879021356 ()
74283

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

Almond - 00816879021349

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
F020
Not in Commercial Distribution

  • 00816879021349 ()
74273

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

Tomato - 00816879021240

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
F025
Not in Commercial Distribution

  • 00816879021240 ()
74245

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