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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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TdT, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59720 ()
BSB 5972

  • Terminal deoxynucleotidyl transferase (TdT) IVD, control
Renal Cell Carcinoma, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59160 ()
BSB 5916

  • Renal cell carcinoma antigen IVD, control
PSAP, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59090 ()
BSB 5909

  • Metachromatic leukodystrophy IVD, control
PSA Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59020 ()
BSB 5902

  • Complexed prostate specific antigen (cPSA) IVD, control
Prolactin, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58950 ()
BSB 5895

  • Prolactin IVD, control
PAX-5, Control Slides
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58670 ()
BSB 5867

  • B-cell specific activator protein (BSAP) IVD, control
Parvovirus, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58600 ()
BSB 5860

  • Parvovirus B19 antigen IVD, control
Myelin Basic Protein Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB57840 ()
BSB 5784

  • Myelin basic protein IVD, control
MSH2 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB57770 ()
BSB 5777

  • MSH2 antigen IVD, control
Melanosome HMB45, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB57630 ()
BSB 5763

  • Melanosome IVD, control
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