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

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control
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
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
This reagent is intended for the detection of the E antigen on red blood cells. This E antigen is part of the Rhesus blood group system.
IMMUCOR, INC.
0066422
In Commercial Distribution

  • 10888234001362 ()
0066422

  • Anti-E [RH003] red blood cell grouping IVD, antibody
This Anti-e reagent is for the in vitro detection and identification of the human e blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z096U
In Commercial Distribution

  • 05060242471674 ()
  • 05060242472565 ()
  • 05060242472572 ()


  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-E (Human/Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z073U
In Commercial Distribution

  • 05060242471469 ()
  • 05060242471315 ()


  • Anti-E [RH003] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813242100
In Commercial Distribution

  • 07611969964727 ()
813242100

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813240100
In Commercial Distribution

  • 07611969964710 ()
813240100

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813222100
In Commercial Distribution

  • 07611969964680 ()
813222100

  • Anti-E [RH003] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813220100
In Commercial Distribution

  • 07611969964673 ()
813220100

  • Anti-E [RH003] red blood cell grouping IVD, antibody
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