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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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House Dust Mite D.pteronyssinus - 00816879021110

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
D001
Not in Commercial Distribution

  • 00816879021110 ()
74201

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

NOVEOS Redtop, Bentgrass, Agrostis stolonifera - 00816879029932

No Description
HYCOR BIOMEDICAL LLC
G009
In Commercial Distribution

  • 00816879029932 ()
8634620Z

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

NOVEOS Cocksfoot, Dactylis glomerata - 00816879029925

No Description
HYCOR BIOMEDICAL LLC
G003
In Commercial Distribution

  • 00816879029925 ()
63280Z

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

NOVEOS Cow's Milk, Bos taurus - 00816879029918

No Description
HYCOR BIOMEDICAL LLC
F002
In Commercial Distribution

  • 00816879029918 ()
63219Z

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

NOVEOS Egg White, Gallus gallus - 00816879029901

No Description
HYCOR BIOMEDICAL LLC
F001
In Commercial Distribution

  • 00816879029901 ()
63218Z

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

NOVEOS Common Silver Birch, Betula verrucosa - 00816879029895

No Description
HYCOR BIOMEDICAL LLC
T003
In Commercial Distribution

  • 00816879029895 ()
63308Z

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

NOVEOS Dog Dander, Canis familiaris - 00816879029888

No Description
HYCOR BIOMEDICAL LLC
E005
In Commercial Distribution

  • 00816879029888 ()
63215Z

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

NOVEOS Common Ragweed, Ambrosia artemisiifolia - 00816879029871

No Description
HYCOR BIOMEDICAL LLC
W001
In Commercial Distribution

  • 00816879029871 ()
63330Z

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

NOVEOS Bermuda Grass, Cynodon dactylon - 00816879029864

No Description
HYCOR BIOMEDICAL LLC
G002
In Commercial Distribution

  • 00816879029864 ()
8632790Z

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

NOVEOS Oak, Quercus alba - 00816879029857

No Description
HYCOR BIOMEDICAL LLC
T007
In Commercial Distribution

  • 00816879029857 ()
63312Z

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