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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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IgE AccuLite CLIA Test System - 960 Wells - 00816870021959

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021959 ()

  • Width: 12 Inch
2575-300E

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 480 Wells - 00816870021942

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021942 ()

  • Width: 12 Inch
2575-300D

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Monobind AccuLite IgE CLIA Kit - 96 Wells - 00816870021928

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021928 ()

  • Width: 7.75 Inch
2575-300A

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 192 Wells - 00816870021935

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021935 ()

  • Width: 7.75 Inch
2575-300B

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Solid Abutment - 08800039305754

No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HISS5544
In Commercial Distribution

  • 08800039305754 ()


  • Haemoglobin E (HbE) IVD, calibrator

Alinity - 00380740153700

IgE Reagent Kit 200 tests
ABBOTT LABORATORIES
01R1321
In Commercial Distribution

  • 00380740153700 ()
01R1321

  • Total immunoglobulin E (IgE total) IVD, kit, nephelometry/turbidimetry

Access Total IgE - 15099590221324

The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35000
Not in Commercial Distribution

  • 15099590221324 ()
35000

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Access Total IgE Calibrators - 15099590221317

The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35005
Not in Commercial Distribution

  • 15099590221317 ()
35005

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Access Total IgE Calibrator S0 - 15099590221300

The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator.
Beckman Coulter, Inc.
35006
In Commercial Distribution

  • 15099590221300 ()
35006

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740030100

Quantia IgE Calibrators
ABBOTT LABORATORIES
6K50-02
In Commercial Distribution

  • 00380740030100 ()
06K5002

  • Total immunoglobulin E (IgE total) IVD, calibrator
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