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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)

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)

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) - 23661562495584

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
DIAGAST
B49558
In Commercial Distribution

  • 23661562495584 ()
B49558

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

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) - 23661562173192

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems
DIAGAST
17319
In Commercial Distribution

  • 23661562173192 ()
17319

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