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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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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
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