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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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; 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
10-Panel T-Square with indicator; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
QODOA-10106EUO-I
In Commercial Distribution

  • 10816862022916 ()
  • 00816862022919 ()
  • 00816862022926 ()
QODOA-10106EUO-I

  • 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

  • 10816862020738 ()
  • 00816862020731 ()
  • 00816862029734 ()
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

  • 10816862020691 ()
  • 00816862020694 ()
  • 00816862029697 ()
WDOA-6125

  • 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

  • 10816862020516 ()
  • 00816862020519 ()
  • 00816862029512 ()
WDOA-1125

  • 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

  • 10816862020318 ()
  • 00816862020311 ()
  • 00816862029314 ()
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

  • 10816862020257 ()
  • 00816862020250 ()
  • 00816862029253 ()
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

  • 10816862020233 ()
  • 00816862020236 ()
  • 00816862029239 ()
TDOA-6124

  • 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
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
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
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
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
SAFElife 8-Panel T-Cup Compact without THC; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI
WONDFO USA CO., LTD.
CDOA-1085NT
In Commercial Distribution

  • 10816862027348 ()
  • 00816862027341 ()
  • 00816862027334 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
FIRST CHECK DIAGNOSTIC CORP.
THC Test- 2 pack
Not in Commercial Distribution

  • 00643281801128 ()
  • 00643281990402 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZO) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, Cocaine and THC metabolites in urine.
BTNX Inc
D6.1-1G29-25
In Commercial Distribution

  • 00722066000892 ()
  • 00722066004111 ()
D6.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution

  • 00860004081661 ()
  • 00860004081654 ()
  • 00860004081647 ()
P33-10-MET

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/THC
HEMOSURE INC.
FSCW11024
In Commercial Distribution

  • 00857338006484 ()
  • 00841824101890 ()
FSCW11024

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure COC/THC
HEMOSURE INC.
FSCW124
In Commercial Distribution

  • 00857338006460 ()
  • 00841824100152 ()
FSCW124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)
IDUN SOLUTIONS LLC
21115061010308-B
In Commercial Distribution

  • 00857275007438 ()
  • 00857275007537 ()


  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (BZO 300 • COC 300 • MET 1000 • MOP 300 • THC 50)
IDUN SOLUTIONS LLC
21505040010308
In Commercial Distribution

  • 00857275007391 ()
  • 00857275007513 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
COC/THC/BZO/AMP/BAR/OPI2000/MET/MDMA/TCA/PCP drugs of abuse tes cup
Twin Spirit Inc.
61015D
Not in Commercial Distribution

  • 00859144006146 ()
61015D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup
Twin Spirit Inc.
61020D
Not in Commercial Distribution

  • 00859144006139 ()
61020D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/BAR/BZO/MET/OPI300/MTD/PPX/OXY/MDMA drugs of abuse test cup
Twin Spirit Inc.
61023D
Not in Commercial Distribution

  • 00859144006122 ()
61023D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/BAR/BZO/MET/OPI300/AMP/PPX/OXY/MDMA drugs of abuse test cup
Twin Spirit Inc.
61025D
Not in Commercial Distribution

  • 00859144006115 ()
61025D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/BAR/BZO/MET/OPI300/PPX/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
61050D
Not in Commercial Distribution

  • 00859144006108 ()
61050D

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