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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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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
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
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
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)
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
ImmunoCAP Allergen Rf307, Hake
Phadia AB
14-5194-10
In Commercial Distribution

  • 07333066008141 ()
14-5194-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rrx1, Regional
Phadia AB
14-5193-10
In Commercial Distribution

  • 07333066008127 ()
14-5193-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rk210, Maleic anhydrid
Phadia AB
14-5190-10
In Commercial Distribution

  • 07333066008066 ()
14-5190-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid
Phadia AB
14-5189-10
In Commercial Distribution

  • 07333066008059 ()
14-5189-10

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