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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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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)

BD Directigen™ Meningitis Test Negative Control Reagent - 30382902523506

BD Directigen™ Meningitis Test Negative Control Reagent
BECTON, DICKINSON AND COMPANY
252350
Not in Commercial Distribution

  • 30382902523506 ()
  • 00382902523505 ()

  • Total Volume: 9 Milliliter
252350

  • Multiple meningitis-associated bacteria antigen IVD, control

Phadebact CSF Positive Controls - 07350049850238

No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control

Phadebact CSF Test - 07350049850221

No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

PANGEA - 07613327625066

Drill Sleeve Insert, MIS
Stryker GmbH
542116
In Commercial Distribution

  • 07613327625066 ()
542116

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit - 00382902555605

BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
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