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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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FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

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


  • Amyloid B component IVD, calibrator
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
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) 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
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 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
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
Alinity s HBsAg Release Control Kit
Abbott Ireland Diagnostics
06P0215
In Commercial Distribution

  • 00380740136802 ()
06P0215

  • Hepatitis B virus surface antigen IVD, control
Alinity s HBsAg Assay Control Kit
Abbott Ireland Diagnostics
06P0213
In Commercial Distribution

  • 00380740136796 ()
06P0213

  • Hepatitis B virus surface antigen IVD, control
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
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