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 Class Implantable

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AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
ADVIN BIOTECH, INC.
ABCardD-12-01
In Commercial Distribution

  • B115ABCARDD12011 ()
  • B115ABCARDD12010 ()
ABCardD-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCardD-10-16
In Commercial Distribution

  • B115ABCARDD10161 ()
  • B115ABCARDD10160 ()
ABCardD-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI300/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCardD-05-02
In Commercial Distribution

  • B115ABCARDD05021 ()
  • B115ABCARDD05020 ()
ABCardD-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCardC-12-71
In Commercial Distribution

  • B115ABCARDC12710 ()
  • B115ABCARDC12711 ()
ABCardC-12-71

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCardC-12-44
In Commercial Distribution

  • B115ABCARDC12440 ()
  • B115ABCARDC12441 ()
ABCardC-12-44

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-07-43
In Commercial Distribution

  • B115ABCARDC07430 ()
  • B115ABCARDC07431 ()
ABCardC-07-43

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI300/OXY100/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-07-03
In Commercial Distribution

  • B115ABCARDC07031 ()
  • B115ABCARDC07030 ()
ABCardC-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60505N-3A
In Commercial Distribution

  • 00858984006248 ()
ND-60505N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI2000/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60500N-3A
In Commercial Distribution

  • 00858984006224 ()
ND-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Datascope Trio Compatible Oximax Direct Connect Ear Clip Sensor
APK Technology Co.,Ltd.
10306
In Commercial Distribution

  • 06946725554357 ()


  • Tissue saturation oximeter sensor, reprocessed
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