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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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BCA-225 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50700 ()
BSB 5070

  • Breast carcinoma antigen 225 (BCA-225) IVD, control
AMACRacemase / P504S Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50630 ()
BSB 5063

  • p504s protein IVD, control
Alpha-Fetoprotein Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50560 ()
BSB 5056

  • Alpha-fetoprotein (AFP) IVD, control
ALK-1 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50490 ()
BSB 5049

  • Anaplastic lymphoma kinase IVD, control
Adenovirus Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50420 ()
BSB 5042

  • Adenovirus antigen IVD, control
Actin Smooth Muscle Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50350 ()
BSB 5035

  • Smooth muscle actin IVD, control
Actin Muscle Specific Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50280 ()
BSB 5028

  • Muscle-specific alpha/gamma actin IVD, control
ACTH, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50210 ()
BSB 5021

  • Adrenocorticotropic hormone (ACTH) IVD, control
A-1-Antitrypsin Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB50140 ()
BSB 5014

  • Gross cystic disease fluid protein-15 IVD, antibody
A-1-Antichymotrypsin Control
BIO SB, INC.
Control Slide, 5
In Commercial Distribution

  • B502BSB50070 ()
BSB 5007

  • Alpha-1-antichymotrypsin IVD, control
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