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

  • 06971674866664 ()


  • Apolipoprotein E (Apo E) IVD, reagent
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™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)
No Description
HYCOR BIOMEDICAL LLC
74154
Not in Commercial Distribution

  • 00816879022100 ()
74154

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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
UP20 Negative Control Reagent
Minaris Medical America, Inc.
80108
Not in Commercial Distribution

  • 00813382010358 ()
  • 00813382010365 ()
80108

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
UP20 Positive Control Reagent
Minaris Medical America, Inc.
80107
Not in Commercial Distribution

  • 00813382010280 ()
  • 00813382010341 ()
80107

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
CLA Pos Ctrl Serum
Minaris Medical America, Inc.
93026
In Commercial Distribution

  • 00813382010198 ()
  • 00813382010303 ()
93026

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
CLA Neg Ctrl Serum
Minaris Medical America, Inc.
94173
In Commercial Distribution

  • 00813382010181 ()
  • 00813382010297 ()
94173

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