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

  • B502BSB59370 ()
BSB 5937

  • Somatostatin IVD, control
Myosin,Smooth Muscle Heavy Chain Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59300 ()
BSB 5930

  • Smooth muscle myosin IVD, control
S-100 control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB59230 ()
BSB 5923

  • S100 protein 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
Progesterone Receptor, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58880 ()
BSB 5888

  • Progesterone receptor IVD, control
Pneumocystis jirovecii Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58810 ()
BSB 5881

  • Pneumocystis jirovecii antigen IVD, control
PLAP, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB58740 ()
BSB 5874

  • Human placental alkaline phosphatase (hPLAP) IVD, control
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