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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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anti-Cytokeratin 14 Mouse Monoclonal Antibody [LL002], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8300-C010
In Commercial Distribution

  • 00615233001276 ()
8300-C010

  • Cytokeratin IVD, antibody
anti-Cytokeratin LMW (CK8/18) Antibody Cocktail [EP17/DC10], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8298-C010
In Commercial Distribution

  • 00615233001269 ()
8298-C010

  • Cytokeratin IVD, antibody
anti-Cytokeratin LMW (CK8/18) Antibody Cocktail [EP17/DC10], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8298-M250
In Commercial Distribution

  • 00615233001252 ()
8298-M250

  • Cytokeratin IVD, antibody
anti-Cytokeratin 7 Mouse Monoclonal Antibody [OV-TL 12/30], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8296-M250
In Commercial Distribution

  • 00615233001245 ()
8296-M250

  • Cytokeratin IVD, antibody
anti-Cytokeratin 7 Mouse Monoclonal Antibody [OV-TL 12/30], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8296-C010
In Commercial Distribution

  • 00615233001238 ()
8296-C010

  • Cytokeratin IVD, antibody
anti-Cytokeratin 5/6 Mouse Monoclonal Antibody [D5/16 B4], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8295-C010
In Commercial Distribution

  • 00615233001221 ()
8295-C010

  • Cytokeratin IVD, antibody
anti-Cytokeratin 5/6 Mouse Monoclonal Antibody [D5/16 B4], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8295-M250
In Commercial Distribution

  • 00615233001214 ()
8295-M250

  • Cytokeratin IVD, antibody
anti-Cytokeratin HMW (CK5) Mouse Monoclonal Antibody [GM028], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8294-M250
In Commercial Distribution

  • 00615233001207 ()
8294-M250

  • Cytokeratin IVD, antibody
anti-Cytokeratin HMW (CK5) Mouse Monoclonal Antibody [GM028], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8294-C010
In Commercial Distribution

  • 00615233001191 ()
8294-C010

  • Cytokeratin IVD, antibody
Alternate name : Pan Cytokeratin Plus [AE1/AE3+8/18]
BIOCARE MEDICAL LLC
AVI162G
In Commercial Distribution

  • 00847627031044 ()


  • Cytokeratin IVD, antibody
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