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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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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
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
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
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
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