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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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CLA® Allergen-Specific IgE Assay - Eastern - 00813382010105

KIT, Eastern
Minaris Medical America, Inc.
84502
In Commercial Distribution

  • 00813382010105 ()
84502

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

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel - 00813382010075

KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

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

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

N Latex IgE mono - 00842768008078

Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin E Flex® reagent cartridge - 00842768006173

For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445902
In Commercial Distribution

  • 00842768006173 ()
  • 00842768020087 ()
K7054

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

IMMULITE® 2000 Systems SPE Specific IgE Universal Kit - 00630414982939

Allergen-Specific IgE - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708840
In Commercial Distribution

  • 00630414982939 ()
L2KUN6(D)

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

Immunoglobulin E (IgE) ELISA - 04048474017885

The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1788
In Commercial Distribution

  • 04048474017885 ()
EIA-1788

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

Immunoglobulin E (IgE) ELISA - 00840239017888

The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
DRG International Inc
EIA-1788
In Commercial Distribution

  • 00840239017888 ()
EIA-1788

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