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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 - 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 - Western Inhalant Panel - 00813382010167

KIT, Western Inhalant
Minaris Medical America, Inc.
84511
Not in Commercial Distribution

  • 00813382010167 ()
84511

  • 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

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

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)

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

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)

ImmunoCAP Allergen t225, Allergen component rBet v 6 Birch - 07333066010533

ImmunoCAP Allergen t225, Allergen component rBet v 6 Birch
Phadia AB
14-5345-01
In Commercial Distribution

  • 07333066010533 ()
14-5345-01

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

ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut - 07333066010496

ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut
Phadia AB
14-5341-01
In Commercial Distribution

  • 07333066010496 ()
14-5341-01

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

ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timothy - 07333066010441

ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timothy
Phadia AB
14-5338-01
In Commercial Distribution

  • 07333066010441 ()
14-5338-01

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

ImmunoCAP Allergen c7, Cefaclor - 07333066010427

ImmunoCAP Allergen c7, Cefaclor
Phadia AB
14-5336-10
In Commercial Distribution

  • 07333066010427 ()
14-5336-10

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

ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST - 07333066009841

ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST
Phadia AB
14-5301-10
In Commercial Distribution

  • 07333066009841 ()
14-5301-10

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

ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus - 07333066009780

ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus
Phadia AB
14-5296-10
In Commercial Distribution

  • 07333066009780 ()
14-5296-10

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

ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus - 07333066009766

ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus
Phadia AB
14-5295-10
In Commercial Distribution

  • 07333066009766 ()
14-5295-10

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

ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profilin, Timothy - 07333066009698

ImmunoCAP Allergen g212, Allergen component rPhl p 12 Profilin, Timothy
Phadia AB
14-5292-01
In Commercial Distribution

  • 07333066009698 ()
14-5292-01

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