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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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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

IgE-XR AccuBind ELISA Test System - 96 Wells - 00816870024400

No Description
MONOBIND, INC.
13025-300
In Commercial Distribution

  • 00816870024400 ()

  • Width: 7.75 Inch
13025-300A

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

IgE AccuBind ELISA Test System - 960 Wells - 00816870020273

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020273 ()

  • Width: 12 Inch
2525-300E

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

IgE AccuBind ELISA Test System - 480 Wells - 00816870020266

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020266 ()

  • Width: 12 Inch
2525-300D

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

Monobind AccuBind IgE ELISA Kit - 192 Wells - 00816870020259

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020259 ()

  • Width: 7.75 Inch
2525-300B

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

IgE AccuBind ELISA Test System - 96 Wells - 00816870020242

No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020242 ()

  • Width: 7.75 Inch
2525-300A

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

ImmunoCAP Total IgE Anti-IgE - 07333066004037

ImmunoCAP Total IgE Anti-IgE
Phadia AB
14-4509-01
In Commercial Distribution

  • 07333066004037 ()
14-4509-01

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

ImmunoCAP Total IgE Conjugate 400 - 07333066019864

ImmunoCAP Total IgE Conjugate 400
Phadia AB
34-2325-42
In Commercial Distribution

  • 07333066000664 ()
  • 07333066019864 ()
34-2325-42

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

ImmunoCAP Total IgE Calibrator Strip - 07333066019796

ImmunoCAP Total IgE Calibrator Strip
Phadia AB
34-2274-81
In Commercial Distribution

  • 07333066000367 ()
  • 07333066019796 ()
34-2274-81

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