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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-B (Murine Monoclonal) Series 3 - 10888234001997

Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006407
In Commercial Distribution

  • 10888234001997 ()
0006407

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Gamma-clone - 10888234001720

This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0413210
In Commercial Distribution

  • 10888234001720 ()
0413210

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Gamma-clone - 10888234001713

This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0413203
In Commercial Distribution

  • 10888234001713 ()
0413203

  • Anti-B red blood cell grouping IVD, antibody

Anti-B (Murine Monoclonal) Series 3 - 10888234000532

Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006406
In Commercial Distribution

  • 10888234000532 ()
0006406

  • Anti-B red blood cell grouping IVD, antibody

Alinity - 00380740136802

Alinity s HBsAg Release Control Kit
Abbott Ireland Diagnostics
06P0215
In Commercial Distribution

  • 00380740136802 ()
06P0215

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740136796

Alinity s HBsAg Assay Control Kit
Abbott Ireland Diagnostics
06P0213
In Commercial Distribution

  • 00380740136796 ()
06P0213

  • Hepatitis B virus surface antigen IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

PreciControl HBsAg II Auto Confirm - 07613336183236

No Description
Roche Diagnostics GmbH
08741107162
In Commercial Distribution

  • 07613336183236 ()
08741107162

  • Hepatitis B virus surface antigen IVD, control

PreciControl HBsAg II - 07613336183168

No Description
Roche Diagnostics GmbH
04687876162
In Commercial Distribution

  • 07613336183168 ()
04687876162

  • Hepatitis B virus surface antigen IVD, control
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