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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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ImmunoCAP Allergen g3, Cocksfoot - 07333066001234

ImmunoCAP Allergen g3, Cocksfoot
Phadia AB
14-4117-01
In Commercial Distribution

  • 07333066001234 ()
14-4117-01

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

ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.) - 07333066001227

ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.)
Phadia AB
14-4116-01
In Commercial Distribution

  • 07333066001227 ()
14-4116-01

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

ImmunoCAP Allergen f14, Soybean - 07333066001210

ImmunoCAP Allergen f14, Soybean
Phadia AB
14-4115-01
In Commercial Distribution

  • 07333066001210 ()
14-4115-01

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

ImmunoCAP Allergen f4, Wheat - 07333066001203

ImmunoCAP Allergen f4, Wheat
Phadia AB
14-4113-01
In Commercial Distribution

  • 07333066001203 ()
14-4113-01

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

ImmunoCAP Allergen f2, Milk - 07333066001197

ImmunoCAP Allergen f2, Milk
Phadia AB
14-4112-01
In Commercial Distribution

  • 07333066001197 ()
14-4112-01

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

ImmunoCAP Allergen f1, Egg white - 07333066001180

ImmunoCAP Allergen f1, Egg white
Phadia AB
14-4111-01
In Commercial Distribution

  • 07333066001180 ()
14-4111-01

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

ImmunoCAP Allergen e5, Dog dander - 07333066001173

ImmunoCAP Allergen e5, Dog dander
Phadia AB
14-4110-01
In Commercial Distribution

  • 07333066001173 ()
14-4110-01

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

ImmunoCAP Allergen e1, Cat dander - 07333066001166

ImmunoCAP Allergen e1, Cat dander
Phadia AB
14-4109-01
In Commercial Distribution

  • 07333066001166 ()
14-4109-01

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

ImmunoCAP Allergen d2, House dust mite - 07333066001159

ImmunoCAP Allergen d2, House dust mite
Phadia AB
14-4108-01
In Commercial Distribution

  • 07333066001159 ()
14-4108-01

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

ImmunoCAP Allergen d1, House dust mite - 07333066001142

ImmunoCAP Allergen d1, House dust mite
Phadia AB
14-4107-01
In Commercial Distribution

  • 07333066001142 ()
14-4107-01

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

ImmunoCAP Allergen m6, Alternaria alternata - 07333066001135

ImmunoCAP Allergen m6, Alternaria alternata
Phadia AB
14-4106-01
In Commercial Distribution

  • 07333066001135 ()
14-4106-01

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

ImmunoCAP Allergen w21, Wall pellitory - 07333066001111

ImmunoCAP Allergen w21, Wall pellitory
Phadia AB
14-4104-01
In Commercial Distribution

  • 07333066001111 ()
14-4104-01

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

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (100ND) - 00813382012185

KIT, OPTIGEN US Environmental 36 (100ND)
Minaris Medical America, Inc.
85268
In Commercial Distribution

  • 00813382012185 ()
85268

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

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) - 00813382012178

KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

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

OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND) - 00813382012154

KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

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

OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) - 00813382010440

KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

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

OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) - 00813382010433

KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

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

OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) - 00813382010426

KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

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

OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel - 00813382010396

KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

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

OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel - 00813382010389

KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

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

OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel - 00813382010372

KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

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

CLA® Allergen-Specific IgE Assay - Eastern - 00813382010334

Kit, Southern
Minaris Medical America, Inc.
84508
Not in Commercial Distribution

  • 00813382010334 ()
84508

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

CLA® Allergen-Specific IgE Assay - Moderate Food Panel - 00813382010174

KIT, Moderate Food
Minaris Medical America, Inc.
84518
In Commercial Distribution

  • 00813382010174 ()
84518

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

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel - 00813382010150

KIT, Southwestern Inhalant
Minaris Medical America, Inc.
84509
Not in Commercial Distribution

  • 00813382010150 ()
84509

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

CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel - 00813382010143

KIT, Southeastern Inhalant
Minaris Medical America, Inc.
84507
In Commercial Distribution

  • 00813382010143 ()
84507

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

CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel - 00813382010136

KIT, Pediatric Comprehensive
Minaris Medical America, Inc.
84506
Not in Commercial Distribution

  • 00813382010136 ()
84506

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

CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel - 00813382010129

KIT, Northwestern Inhalant
Minaris Medical America, Inc.
84505
Not in Commercial Distribution

  • 00813382010129 ()
84505

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

CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel - 00813382010112

KIT, Northeastern Inhalant
Minaris Medical America, Inc.
84504
In Commercial Distribution

  • 00813382010112 ()
84504

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

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)

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
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