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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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BIOCARE MEDICAL LLC
CM234A
In Commercial Distribution

  • 00847627006936 ()


  • Cytokeratin IVD, antibody
anti-Cytokeratin 19 Mouse Monoclonal Antibody [A53-B/A2.26], Ready-To-Use, 7 mL
SAKURA FINETEK U.S.A., INC.
60-0163-7
In Commercial Distribution

  • 00615233006011 ()
60-0163-7

  • Cytokeratin IVD, antibody
anti-Cytokeratin 5 Mouse Monoclonal Antibody [GM028], Ready-To-Use, 7 mL
SAKURA FINETEK U.S.A., INC.
60-0174-7
In Commercial Distribution

  • 00615233005984 ()
60-0174-7

  • Cytokeratin IVD, antibody
anti-Cytokeratin 5/6 Mouse Monoclonal Antibody [D5/16B4], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0016
In Commercial Distribution

  • 00615233005168 ()
61-0016

  • Cytokeratin IVD, antibody
anti-Cytokeratin 18 Mouse Monoclonal Antibody [DC-10], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0017
In Commercial Distribution

  • 00615233005144 ()
61-0017

  • Cytokeratin IVD, antibody
anti-Cytokeratin 20 Mouse Monoclonal Antibody [Ks20.8], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0018
In Commercial Distribution

  • 00615233005113 ()
61-0018

  • Cytokeratin IVD, antibody
anti-Cytokeratin 7 Mouse Monoclonal Antibody [OV-TL 12/30], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0019
In Commercial Distribution

  • 00615233005083 ()
61-0019

  • Cytokeratin IVD, antibody
anti-Cytokeratin Mouse Monoclonal Antibody Cocktail [AE1/AE3], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0022
In Commercial Distribution

  • 00615233004994 ()
61-0022

  • Cytokeratin IVD, antibody
anti-Cytokeratin Mouse Monoclonal Antibody [AE1], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0023
In Commercial Distribution

  • 00615233004963 ()
61-0023

  • Cytokeratin IVD, antibody
anti-Cytokeratin HMW Mouse Monoclonal Antibody [34bE12], Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0025
In Commercial Distribution

  • 00615233004932 ()
61-0025

  • Cytokeratin IVD, antibody
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