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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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AMP500/BZO300/COC150/MET500/OPI2000
ADVIN BIOTECH, INC.
ABCard-05-45
In Commercial Distribution

  • B115ABCARD05451 ()
  • B115ABCARD05450 ()
ABCard-05-45

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/MTD300/OPI300/OXY100/THC50
ADVIN BIOTECH, INC.
ABCard-05-39
In Commercial Distribution

  • B115ABCARD05391 ()
  • B115ABCARD05390 ()
ABCard-05-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MDMA500/OPI300/THC50
ADVIN BIOTECH, INC.
ABCard-05-36
In Commercial Distribution

  • B115ABCARD05361 ()
  • B115ABCARD05360 ()
ABCard-05-36

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/PCP25/THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05231 ()
  • B115ABCARD05230 ()
ABCard-05-23

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/MDMA500/MET500/OPI2000/THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05141 ()
  • B115ABCARD05140 ()
ABCard-05-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/ME500T/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03021 ()
  • B115ABCARD03020 ()
ABCard-03-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03011 ()
  • B115ABCARD03010 ()
ABCard-03-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/THC50
ADVIN BIOTECH, INC.
ABCard-02-05
In Commercial Distribution

  • B115ABCARD02051 ()
  • B115ABCARD02050 ()
ABCard-02-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/THC20
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD02041 ()
  • B115ABCARD02040 ()
ABCard-02-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP5/OXY100
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD02031 ()
  • B115ABCARD02030 ()
ABCard-02-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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