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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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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

ALBAclone Anti-B - 05060242471438

Blood Grouping Reagent, ALBAclone Anti-B (Murine Monoclonal IgM) for slide and tube techniques.
ALBA BIOSCIENCE LIMITED
Z015U
In Commercial Distribution

  • 05060242471438 ()
  • 05060242471254 ()
  • 05060242470875 ()


  • Anti-B red blood cell grouping IVD, antibody

Procleix HIV-1/HCV/HBV Quality Control - 00850032683036

Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HBV Positive Control
In Commercial Distribution

  • 00850032683036 ()


  • Hepatitis B virus nucleic acid IVD, control

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 - 00380740136796

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

  • 00380740136796 ()
06P0213

  • Hepatitis B virus surface antigen IVD, control

Alinity - 00380740136802

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

  • 00380740136802 ()
06P0215

  • Hepatitis B virus surface antigen IVD, control
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