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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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UP20 Positive Control Reagent - 00813382010280

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® Positive Control Serum - 00813382010198

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® 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® Negative Control Reagent - 00813382010099

OPTIGEN Negative Control
Minaris Medical America, Inc.
82062
In Commercial Distribution

  • 00813382010099 ()
  • 00813382010310 ()
82062

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

OPTIGEN® Positive Control Reagent - 00813382010082

OPTIGEN Positive Control
Minaris Medical America, Inc.
82061
In Commercial Distribution

  • 00813382010082 ()
  • 00813382010327 ()
82061

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

IgE CAL SET - 05055273203912

This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
IE2492
In Commercial Distribution

  • 05055273203912 ()
IE2492

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

ADVIA Centaur® Systems Calibrator 80 - 00630414580111

IgE - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10492491
In Commercial Distribution

  • 00630414580111 ()
10492491

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

Atellica IM Calibrator 80 - 00630414598246

Calibrator 80 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995497
In Commercial Distribution

  • 00630414598246 ()
  • 00630414190716 ()
10995497

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

K-ASSAY® Total IgE Calibrator - 00816426020672

For the calibration of the K-ASSAY® Total IgE assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-093C
In Commercial Distribution

  • 00816426020672 ()
KAI-093C

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

IgE - 05055273203929

An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma
RANDOX LABORATORIES LIMITED
IE7308
In Commercial Distribution

  • 05055273203929 ()
IE7308

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