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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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NOVEOS IgE Common Kit - 00816879023008

No Description
HYCOR BIOMEDICAL LLC
63140
Not in Commercial Distribution

  • 00816879023008 ()


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

HYTEC - 00816879022858

No Description
HYCOR BIOMEDICAL LLC
MCS Specific Total IgE Conjugate
Not in Commercial Distribution

  • 00816879022858 ()
308174

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

HYTEC - 00816879022841

No Description
HYCOR BIOMEDICAL LLC
Specific IgE Reference Disc
Not in Commercial Distribution

  • 00816879022841 ()
74112

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

IgE Reference Disc - 00816879022292

No Description
HYCOR BIOMEDICAL LLC
74118
Not in Commercial Distribution

  • 00816879022292 ()


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

PnPP Tablets - 00816879022261

Four vials per package.
HYCOR BIOMEDICAL LLC
308053
Not in Commercial Distribution

  • 00816879022261 ()
74130

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

Elm, Fall Blooming/Scrub Ulmus crassifolia - 00816879022056

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
T045
Not in Commercial Distribution

  • 00816879022056 ()
749740

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

NOVEOS House Dust Mite, Dermatophagoides farinae - 00816879029253

No Description
HYCOR BIOMEDICAL LLC
D002
In Commercial Distribution

  • 00816879029253 ()
63208Z

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

NOVEOS House Dust Mite, Dermatophagoides pteronyssinus - 00816879029246

No Description
HYCOR BIOMEDICAL LLC
D001
In Commercial Distribution

  • 00816879029246 ()
63207Z

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

NOVEOS Olive Tree, Olea europaea - 00816879028317

No Description
HYCOR BIOMEDICAL LLC
T009
In Commercial Distribution

  • 00816879028317 ()
63314

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

NOVEOS Sheep Sorrel, Rumex acetosella - 00816879028300

No Description
HYCOR BIOMEDICAL LLC
W018
In Commercial Distribution

  • 00816879028300 ()
8633370

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