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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 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
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
Phadia AB
34-2274-81
In Commercial Distribution

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

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

  • 14560189210155 ()
  • 04560189210158 ()


  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066424
In Commercial Distribution

  • 10888234001379 ()
0066424

  • Anti-E [RH005] red blood cell grouping IVD, antibody
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