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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 Control Strip
Phadia AB
34-2274-51
In Commercial Distribution

  • 07333066000220 ()
  • 07333066019789 ()
34-2274-51

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Conjugate 100
Phadia AB
34-2272-22
In Commercial Distribution

  • 07333066000206 ()
  • 07333066019772 ()
34-2272-22

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9517-02
In Commercial Distribution

  • 07333066019673 ()
10-9517-02

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
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)
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)
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)
Quantia IgE Calibrators
ABBOTT LABORATORIES
06K5004
In Commercial Distribution

  • 00380740156367 ()
06K5004

  • Total immunoglobulin E (IgE total) IVD, calibrator
IgE Calibrators
ABBOTT LABORATORIES
01R1302
In Commercial Distribution

  • 00380740153694 ()
01R1302

  • Total immunoglobulin E (IgE total) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211070 ()


  • Total immunoglobulin E (IgE total) IVD, calibrator
Quantia IgE Calibrators
ABBOTT LABORATORIES
6K50-02
In Commercial Distribution

  • 00380740030100 ()
06K5002

  • Total immunoglobulin E (IgE total) IVD, calibrator
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