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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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OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T) - 00813382010037

KIT, OPTIGEN® Environmental 36 (20T)
Minaris Medical America, Inc.
85068
In Commercial Distribution

  • 00813382010037 ()
85068

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND) - 00813382010020

KIT, OPTIGEN US Food 30 (100ND)
Minaris Medical America, Inc.
85267
In Commercial Distribution

  • 00813382010020 ()
85267

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - Food 29 (20T) - 00813382010013

KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010006

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

NOVEOS Fluo Beads - 00816879029642

No Description
HYCOR BIOMEDICAL LLC
K332065-2Z
In Commercial Distribution

  • 00816879029642 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Conjugate IgE - 00816879029635

No Description
HYCOR BIOMEDICAL LLC
K332030-2Z
In Commercial Distribution

  • 00816879029635 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Diluent A Kit - 00816879029628

No Description
HYCOR BIOMEDICAL LLC
K332020-2Z
In Commercial Distribution

  • 00816879029628 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS IgE Calibrator Antibody Pack - 00816879029550

No Description
HYCOR BIOMEDICAL LLC
63180Z
In Commercial Distribution

  • 00816879029550 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS IgE Calibrator Set - 00816879029499

No Description
HYCOR BIOMEDICAL LLC
63125Z
In Commercial Distribution

  • 00816879029499 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Substrate Pack - 00816879029468

No Description
HYCOR BIOMEDICAL LLC
K33218085-4Z
In Commercial Distribution

  • 00816879029468 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Fluo Beads - 00816879028881

No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Substrate Pack - 00816879028850

No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Conjugate IgE - 00816879028836

No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS Diluent A Kit - 00816879028829

No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS IgE Calibrator Antibody Pack - 00816879023077

No Description
HYCOR BIOMEDICAL LLC
63180
In Commercial Distribution

  • 00816879023077 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

NOVEOS IgE Calibrator Set - 00816879023251

No Description
HYCOR BIOMEDICAL LLC
63125
In Commercial Distribution

  • 00816879023251 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Allergen Re218, Chicken droppings - 07333066008813

ImmunoCAP Allergen Re218, Chicken droppings
Phadia AB
14-5229-10
In Commercial Distribution

  • 07333066008813 ()
14-5229-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Allergen Rf324, Hop - 07333066008790

ImmunoCAP Allergen Rf324, Hop
Phadia AB
14-5228-10
In Commercial Distribution

  • 07333066008790 ()
14-5228-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Allergen Rc208, Tetanus toxoid - 07333066008776

ImmunoCAP Allergen Rc208, Tetanus toxoid
Phadia AB
14-5227-10
In Commercial Distribution

  • 07333066008776 ()
14-5227-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Allergen t216, Allergen component rBet v 2 Profilin, Birch - 07333066008752

ImmunoCAP Allergen t216, Allergen component rBet v 2 Profilin, Birch
Phadia AB
14-5226-01
In Commercial Distribution

  • 07333066008752 ()
14-5226-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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