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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TOX/See Drug Screen Test AMP, COC, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5200
In Commercial Distribution

  • 00847817000591 ()
1945200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5216
In Commercial Distribution

  • 00847817000379 ()
1945216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50)
ALERE SAN DIEGO, INC.
DTH-101
In Commercial Distribution

  • 10815845024299 ()
  • 00815845024292 ()
4561089002

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07141 ()
  • B115ABCUPA07140 ()
ABCupA-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07091 ()
  • B115ABCUPA07090 ()
ABCupA-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07071 ()
  • B115ABCUPA07070 ()
ABCupA-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07061 ()
  • B115ABCUPA07060 ()
ABCupA-07-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP/BZO/COC/MDMA/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07041 ()
  • B115ABCUPA07040 ()
ABCupA-07-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/MET/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07031 ()
  • B115ABCUPA07030 ()
ABCupA-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10201 ()
  • B115ABCUP10200 ()
ABCup-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10191 ()
  • B115ABCUP10190 ()
ABCup-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY /PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10161 ()
  • B115ABCUP10160 ()
ABCup-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)+(COC/THC)+(MET/PCP)+BAR300+BZO300+MTD+PPX
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10101 ()
  • B115ABCUP10100 ()
ABCup-10-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10091 ()
  • B115ABCUP10090 ()
ABCup-10-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10061 ()
  • B115ABCUP10060 ()
ABCup-10-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07141 ()
  • B115ABCARDA07140 ()
ABCardA-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07091 ()
  • B115ABCARDA07090 ()
ABCardA-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07071 ()
  • B115ABCARDA07070 ()
ABCardA-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07061 ()
  • B115ABCARDA07060 ()
ABCardA-07-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP/BZO/COC/MDMA/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07041 ()
  • B115ABCARDA07040 ()
ABCardA-07-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/MET/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA07031 ()
  • B115ABCARDA07030 ()
ABCardA-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10201 ()
  • B115ABCARD10200 ()
ABCard-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10191 ()
  • B115ABCARD10190 ()
ABCard-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY /PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10161 ()
  • B115ABCARD10160 ()
ABCard-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)+(COC/THC)+(MET/PCP)+BAR300+BZO300+MTD+PPX
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10101 ()
  • B115ABCARD10100 ()
ABCard-10-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10091 ()
  • B115ABCARD10090 ()
ABCard-10-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10061 ()
  • B115ABCARD10060 ()
ABCard-10-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
Instant Technologies, Inc.
PSD-5N
Not in Commercial Distribution

  • 00817405020706 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
Instant Technologies, Inc.
PSD-5M
Not in Commercial Distribution

  • 00817405020690 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC
Instant Technologies, Inc.
PSCup-5M-W
Not in Commercial Distribution

  • 00817405020584 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWABII saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SWABII-158
In Commercial Distribution

  • 00816036029089 ()
  • 00816036028587 ()
SWABII-158

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SSB-158
In Commercial Distribution

  • 00816036029010 ()
  • 00816036028518 ()
SSB-158

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-234-0
In Commercial Distribution

  • 00816036025661 ()
  • 00816036026149 ()
SDP-234-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single STATDIP CLIA WAIVED Dip Card, Marijuana (THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
DTH-114-0
In Commercial Distribution

  • 00816036025647 ()
  • 00816036026125 ()
DTH-114-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA Single CLIA Waived Test Dipcard, 25Pcs/Box THC
MICRO DISTRIBUTING, L.C
DTH-114
In Commercial Distribution

  • 00816036020048 ()
  • 00816036020437 ()
DTH-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
ImmuTest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA
AMEDITECH INC.
IMD-9AMJ
Not in Commercial Distribution

  • 00816565021325 ()
IMD-9AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-654A3
In Commercial Distribution

  • 10816862020288 ()
  • 00816862020281 ()
  • 00816862029284 ()
TDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-254A3
In Commercial Distribution

  • 10816862020134 ()
  • 00816862020137 ()
  • 00816862029130 ()
TDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
KDOA-274
In Commercial Distribution

  • 10816862020028 ()
  • 00816862020021 ()
  • 00816862029024 ()
KDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY
BRANAN MEDICAL CORPORATION
C-C1016A
Not in Commercial Distribution

  • 00816555020253 ()
C-C1016A

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