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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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DJO SURGICAL - 00888912087636

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-064
In Commercial Distribution

  • 00888912087636 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087629

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-060
In Commercial Distribution

  • 00888912087629 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087612

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-056
In Commercial Distribution

  • 00888912087612 ()


  • Ceramic acetabular liner

Oxeye Daisy Chrysanth. leucanthemum - 00816879022032

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
W007
Not in Commercial Distribution

  • 00816879022032 ()
744470

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

Foxtail, Meadow Alopecurus pratensis - 00816879022025

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
G016
Not in Commercial Distribution

  • 00816879022025 ()
743420

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

Brome Grass Bromus inermis - 00816879022018

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
G011
Not in Commercial Distribution

  • 00816879022018 ()
743410

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

Reed, Common Phragmites communis - 00816879022001

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
G007
Not in Commercial Distribution

  • 00816879022001 ()
74982

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

Willow, Black Salix nigra - 00816879021998

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
T032
Not in Commercial Distribution

  • 00816879021998 ()
74948

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

Pine, White Pinus strobus - 00816879021981

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
T016
Not in Commercial Distribution

  • 00816879021981 ()
74947

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

Ash, White F. americana - 00816879021974

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
T015
Not in Commercial Distribution

  • 00816879021974 ()
74946

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

Hazelnut Corylus avellana - 00816879021967

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
T004
Not in Commercial Distribution

  • 00816879021967 ()
74944

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

Mesquite Prosopis glandulosa (juliflora) - 00816879021950

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
T020
Not in Commercial Distribution

  • 00816879021950 ()
74942

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

Dandelion Taraxacum officinale - 00816879021943

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
W008
Not in Commercial Distribution

  • 00816879021943 ()
74940

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

Ragweed, Giant Ambrosia trifida - 00816879021936

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
W003
Not in Commercial Distribution

  • 00816879021936 ()
74939

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

Fusarium oxysporum - 00816879021929

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
M049
Not in Commercial Distribution

  • 00816879021929 ()
74784

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

Bipolaris spicifera - 00816879021912

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
M046
Not in Commercial Distribution

  • 00816879021912 ()
74752

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

Epicoccum purpurascens - 00816879021905

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
M014
Not in Commercial Distribution

  • 00816879021905 ()
74751

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

Phoma betae - 00816879021899

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
M013
Not in Commercial Distribution

  • 00816879021899 ()
74749

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

Fusarium moniliforme - 00816879021882

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
M009
Not in Commercial Distribution

  • 00816879021882 ()
74746

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

Helminthosporium halodes - 00816879021875

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
M008
Not in Commercial Distribution

  • 00816879021875 ()
74745

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