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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10-Panel Drug Test Cup BZO/COC/THC/MET/MOP/MTD/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
UCC-10-1M-CLIA
In Commercial Distribution

  • 20817038020887 ()
  • 10817038020880 ()
  • 00817038020883 ()
UCC-10-1M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Card COC/THC/MOP/AMP/MET/BZO/BAR/MTD/OXY/BUP
UCP BIOSCIENCES, INC.
UCD-10-2M-CLIA
In Commercial Distribution

  • 20817038020856 ()
  • 10817038020859 ()
  • 00817038020852 ()
UCD-10-2M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY
UCP BIOSCIENCES, INC.
UCD-10-1-CLIA
In Commercial Distribution

  • 20817038020801 ()
  • 10817038020804 ()
  • 00817038020807 ()
UCD-10-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, COC/MET500/MOR/BZO/THC + (Ni/pH/Gl)/(Cr/SG/Bl)
CHEMTRON BIOTECH INC
712E11A-G
In Commercial Distribution

  • 00812203030223 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screen Dip - AMP/BAR/BZO/COC/THC/MTD/MOR/OXY/PCP/PPX
CHEMTRON BIOTECH INC
711J11
In Commercial Distribution

  • 00812203030100 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel STATDIP CLIA WAIVED Dipcard, AMP/BZO/COC/MAMP/MDMA/MOR/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-174-0
In Commercial Distribution

  • 00816036025791 ()
  • 00816036026279 ()
SDP-174-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0
In Commercial Distribution

  • 00816036025036 ()
  • 00816036025203 ()
STATⅡ-2167-3-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 3 in 1 CLIA Waived Test Cup, 25Pcs/Box COC/mAMP/THC
MICRO DISTRIBUTING, L.C
SCP-1237
In Commercial Distribution

  • 00816036021212 ()
  • 00816036021397 ()
SCP-1237

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 Test Dipcard, 25Pcs/Box COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-354
In Commercial Distribution

  • 00816036020253 ()
  • 00816036020635 ()
SDP-354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 Test Dipcard, 25Pcs/Box AMP/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-454
In Commercial Distribution

  • 00816036020192 ()
  • 00816036020574 ()
SDP-454

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 panel test cup, COC/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-2P
Not in Commercial Distribution

  • 00816565020182 ()
IMCA-2P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC/MET1000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMDA-3M
Not in Commercial Distribution

  • 00816565020106 ()
IMDA-3M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived THC
HEMOSURE INC.
FSCDIPTH-25
In Commercial Distribution

  • 00817763020837 ()
  • 00817763021544 ()
FSCDIPTH-25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA12101 ()
  • B115ABCUPA12100 ()
ABCupA-12-10

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

  • B115ABCUPA11071 ()
  • B115ABCUPA11070 ()
ABCupA-11-07

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

  • B115ABCUPA11041 ()
  • B115ABCUPA11040 ()
ABCupA-11-04

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

  • B115ABCUPA11011 ()
  • B115ABCUPA11010 ()
ABCupA-11-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/ BAR/BUP /BZO /COC /MDMA /MET /MTD /PCP/PPX /OXY /TCA /THC /OPI2000
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP14021 ()
  • B115ABCUP14020 ()
ABCup-14-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP /BAR /BUP /BZO /COC /EDDP /MDMA /MET /MOR /MTD /OXY /PCP /TCA /THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP14011 ()
  • B115ABCUP14010 ()
ABCup-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA12101 ()
  • B115ABCARDA12100 ()
ABCardA-12-10

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

  • B115ABCARDA11071 ()
  • B115ABCARDA11070 ()
ABCardA-11-07

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

  • B115ABCARDA11041 ()
  • B115ABCARDA11040 ()
ABCardA-11-04

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

  • B115ABCARDA11011 ()
  • B115ABCARDA11010 ()
ABCardA-11-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MAMP/MTD/PCP/PPX/OXY/TCA/THC/OPI2000
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD14021 ()
  • B115ABCARD14020 ()
ABCard-14-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD14011 ()
  • B115ABCARD14010 ()
ABCard-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC
RAPID DIAGNOSTICS INC
07RD7060-10
In Commercial Distribution

  • 00817830020753 ()

  • Length: 75 Millimeter
07RD7060-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
Instant Technologies, Inc.
PSCup-10CT
Not in Commercial Distribution

  • 00817405020652 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-7125
In Commercial Distribution

  • 00816862025736 ()
WDOA-7125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-6125
In Commercial Distribution

  • 00816862025699 ()
WDOA-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-6124
In Commercial Distribution

  • 00816862025682 ()
WDOA-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BUP,BZO,COC,MDMA,MTD,TCA,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-3124
In Commercial Distribution

  • 00816862025613 ()
WDOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,THC
WONDFO USA CO., LTD.
WDOA-1125
In Commercial Distribution

  • 00816862025514 ()
WDOA-1125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,THC
WONDFO USA CO., LTD.
WDOA-1124
In Commercial Distribution

  • 00816862025507 ()
WDOA-1124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-7125
In Commercial Distribution

  • 00816862025316 ()
TDOA-7125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-6125
In Commercial Distribution

  • 00816862025255 ()
TDOA-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-6124
In Commercial Distribution

  • 00816862025231 ()
TDOA-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,PCP,PPX,THC
WONDFO USA CO., LTD.
TDOA-4124
In Commercial Distribution

  • 00816862025217 ()
TDOA-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3124
In Commercial Distribution

  • 00816862025194 ()
TDOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Square with Indicator; 25 per box; AMP,COC,MET,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
DQODOA-376EUO-I-25BX-A
In Commercial Distribution

  • 10816862023883 ()
  • 00816862023886 ()
  • 00816862023893 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Square with Indicator; 5 per box; AMP,COC,MET,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
DQODOA-376EUO-I-5BX-A
In Commercial Distribution

  • 10816862023869 ()
  • 00816862023862 ()
  • 00816862023879 ()


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