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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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AIA-PACK IgEII Calibrator Set - 04560189211070

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211070 ()


  • Total immunoglobulin E (IgE total) IVD, calibrator

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)

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)

Total IgE ELISA - B24225IGEHUE010

The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-IGEHU-E01
Not in Commercial Distribution

  • B24225IGEHUE010 ()
25-IGEHU-E01

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

PreciControl Anti-HBe - 04015630938872

Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

ARCHITECT - 00380740156367

Quantia IgE Calibrators
ABBOTT LABORATORIES
06K5004
In Commercial Distribution

  • 00380740156367 ()
06K5004

  • Total immunoglobulin E (IgE total) IVD, calibrator

Alinity - 00380740153694

IgE Calibrators
ABBOTT LABORATORIES
01R1302
In Commercial Distribution

  • 00380740153694 ()
01R1302

  • Total immunoglobulin E (IgE total) IVD, calibrator
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