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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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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
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
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 ten (10) vials of reagent.
IMMUCOR, INC.
0413210
In Commercial Distribution

  • 10888234001720 ()
0413210

  • 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
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 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
VITROS Immunodiagnostic Products HBsAg Controls
ORTHO CLINICAL DIAGNOSTICS
6801390
In Commercial Distribution

  • 10758750001149 ()
  • 20758750001146 ()
6801390

  • Hepatitis B virus surface antigen IVD, control
Anti-B BIOCLONE 3x10ml
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901935
In Commercial Distribution

  • 10758750007448 ()
6901935

  • Anti-B red blood cell grouping IVD, antibody
MTS Anti-B (Murine Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080015
In Commercial Distribution

  • 10758750005857 ()
MTS080015

  • Anti-B red blood cell grouping IVD, antibody
ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
711320
In Commercial Distribution

  • 10758750003075 ()
711320

  • Anti-B red blood cell grouping IVD, antibody
No Description
DIASORIN S.P.A.
318251
In Commercial Distribution

  • 28056771500214 ()
  • 08056771500210 ()


  • Hepatitis B virus surface antigen IVD, control
No Description
DIASORIN SPA
318150
In Commercial Distribution

  • 18056771103401 ()
  • 08056771103404 ()


  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
HBV LOD
EXACT DIAGNOSTICS, LLC
HBVLOD
In Commercial Distribution

  • 00812242030703 ()
HBVLOD

  • Hepatitis B virus nucleic acid IVD, control
Hepatitis B Virus Surface Antigen Control Slides
BIO SB, INC.
BSB-9208-CS
In Commercial Distribution

  • B502BSB9208CS0 ()
BSB-9208-CS

  • Hepatitis B virus surface antigen IVD, control
Hepatitis B Virus Core Antigen Control Slides
BIO SB, INC.
BSB-9207-CS
In Commercial Distribution

  • B502BSB9207CS0 ()
BSB-9207-CS

  • Hepatitis B virus core antigen IVD, control
Hepatitis B Virus Surface Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56230 ()
BSB 5623

  • Hepatitis B virus surface antigen IVD, control
Hepatitis B Virus Core Antigen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56160 ()
BSB 5616

  • Hepatitis B virus core antigen IVD, control
No Description
Roche Diagnostics GmbH
08741107162
In Commercial Distribution

  • 07613336183236 ()
08741107162

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
04687876162
In Commercial Distribution

  • 07613336183168 ()
04687876162

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
09366717190
In Commercial Distribution

  • 07613336182994 ()
09366717190

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
08821976190
In Commercial Distribution

  • 07613336166345 ()
08821976190

  • Amyloid B component IVD, calibrator
HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control
HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 125 Anti-HBs 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0078
In Commercial Distribution

  • 00816784020352 ()
2015-0078

  • Hepatitis B virus surface antigen IVD, control
Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml
Bio-Rad Medical Diagnostics GmbH
801350100
In Commercial Distribution

  • 07611969950119 ()
801350100

  • Anti-B red blood cell grouping IVD, antibody
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