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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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BIOBASE - 06971674867920

No Description
Biobase Biodustry(Shandong)Co., Ltd.
Calibrator: 1mL×1
In Commercial Distribution

  • 06971674867920 ()


  • Apolipoprotein E (Apo E) IVD, reagent

BIOBASE - 06971674866688

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×1 R2:6mL×1
In Commercial Distribution

  • 06971674866688 ()


  • Apolipoprotein E (Apo E) IVD, reagent

BIOBASE - 06971674866671

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674866671 ()


  • Apolipoprotein E (Apo E) IVD, reagent

BIOBASE - 06971674866664

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674866664 ()


  • Apolipoprotein E (Apo E) IVD, reagent

Hytec Specific/Total IgE EIA - 00816879022100

No Description
HYCOR BIOMEDICAL LLC
74154
Not in Commercial Distribution

  • 00816879022100 ()
74154

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

Allereye® Tear Total IgE Test Kit - 00864525000408

Allereye® is a rapid immunoassay for the detection of total IgE in tears.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000408 ()
380003G

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

QMedix™ - 00850054026477

QMedix™Total Human IgE ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1801-18
In Commercial Distribution

  • 00850054026477 ()

  • 96 Tests
1801-18

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

Pointe Scientific, Inc. - 00811727013330

IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests.
POINTE SCIENTIFIC, INC.
P1035-96
In Commercial Distribution

  • 00811727013330 ()
P1035-96

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

CLA® Negative Control Serum - 00813382010181

CLA Neg Ctrl Serum
Minaris Medical America, Inc.
94173
In Commercial Distribution

  • 00813382010181 ()
  • 00813382010297 ()
94173

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control

OPTIGEN® US Panel Control Reagent - 00813382010402

KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
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