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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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ImmunoCAP Total IgE Curve Controls - 07333066019529

Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9257-01
In Commercial Distribution

  • 07333066019529 ()
10-9257-01

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

ImmunoCAP Total IgE Calibrators - 07333066019512

Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method.
Phadia AB
10-9252-01
In Commercial Distribution

  • 07333066019512 ()
10-9252-01

  • 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)

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

AIA-PACK IgEII Calibrator Set - 04560189211070

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211070 ()


  • Total immunoglobulin E (IgE total) IVD, calibrator

ARCHITECT - 00380740030100

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

  • 00380740030100 ()
06K5002

  • Total immunoglobulin E (IgE total) IVD, calibrator

PreciControl Anti-HBe - 04015630938872

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

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

ST AIA-PACK IgEII - 14560189210155

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210155 ()
  • 04560189210158 ()


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

Fluorescent Pink Tinted Monomer - D851E0

Tinted Liquid
JBC and Company
E
In Commercial Distribution

  • D851E0 ()
E

  • Dental appliance fabrication material, resin
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