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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AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA12011 ()
  • B115ABCARDA12010 ()
ABCardA-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

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

  • 00817405020881 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+MTD+PPX
Instant Technologies, Inc.
PSD-10MOX
Not in Commercial Distribution

  • 00817405020768 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD
Instant Technologies, Inc.
PSD-10MOB
Not in Commercial Distribution

  • 00817405020751 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWABII saliva device, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SWABII-1108
In Commercial Distribution

  • 00816036029119 ()
  • 00816036028617 ()
SWABII-1108

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SSB-1108
In Commercial Distribution

  • 00816036029065 ()
  • 00816036028563 ()
SSB-1108

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box AMP/BAR/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC
MICRO DISTRIBUTING, L.C
SSB-4108
In Commercial Distribution

  • 00816036029034 ()
  • 00816036028532 ()
SSB-4108

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

  • 00816036026583 ()
  • 00816036027085 ()
SCP-2167-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8-Panel STATDIP CLIA WAIVED Dipcard, BAR/BZO/COC/MAMP/MOR/MTD/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-384-0
In Commercial Distribution

  • 00816036025814 ()
  • 00816036026293 ()
SDP-384-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-184-0
In Commercial Distribution

  • 00816036025807 ()
  • 00816036026286 ()
SDP-184-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATII-6357
In Commercial Distribution

  • 00816036021632 ()
  • 00816036021649 ()
STATII-6357

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA WaivedTest Cup, 25Pcs/Box THC/COC/OPI/mAMP/PCP
MICRO DISTRIBUTING, L.C
SCP-3257
In Commercial Distribution

  • 00816036021618 ()
  • 00816036021625 ()
SCP-3257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 CLIA Waived Test Cup, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-1247
In Commercial Distribution

  • 00816036021229 ()
  • 00816036021403 ()
SCP-1247

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 Test Dipcard, 25Pcs/Box AMP/COC/mAMP/MOR/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-564
In Commercial Distribution

  • 00816036020307 ()
  • 00816036020680 ()
SDP-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SDP-254
In Commercial Distribution

  • 00816036020246 ()
  • 00816036020628 ()
SDP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-3P
Not in Commercial Distribution

  • 00816565020199 ()
IMCA-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup
AMEDITECH INC.
C-C1016A
Not in Commercial Distribution

  • 00816565020564 ()
C-C1016A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcard
AMEDITECH INC.
IMD-12MO3
Not in Commercial Distribution

  • 00816565020076 ()
IMD-12MO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Dip Drug Screen (THC/COC/MOP/AMP/MET/PCP/BAR/BZO/MDMA/MTD/OXY)
WONDFO USA CO., LTD.
WD-11MT
In Commercial Distribution

  • 10816862020370 ()
  • 00816862020373 ()
  • 00816862029376 ()
WD-11MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7104A3
In Commercial Distribution

  • 10816862020301 ()
  • 00816862020304 ()
  • 00816862029307 ()
TDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC with 3 AD
WONDFO USA CO., LTD.
TDOA-4105A3
In Commercial Distribution

  • 10816862020998 ()
  • 00816862020991 ()
  • 00816862029994 ()
TDOA-4105A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 10816862020929 ()
  • 00816862020922 ()
  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 10816862020189 ()
  • 00816862020182 ()
  • 00816862029185 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 10816862020103 ()
  • 00816862020106 ()
  • 00816862029109 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 7-Panel T-Cup; 25 per box; AMP,BZO,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
DTDOA-274-25BX-A
In Commercial Distribution

  • 10816862024910 ()
  • 00816862024913 ()
  • 00816862024906 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Panel Urine Test (5-Panel Card: AMP, COC, mAMP, OPI, THC), 5T/Bo
WONDFO USA CO., LTD.
DWDOA-254-5BX-A
In Commercial Distribution

  • 10816862023982 ()
  • 00816862023985 ()
  • 00816862023992 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 5-Panel T-Square with indicator; 5 per Box; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
DQODOA-256EUO-I-5BX-A
In Commercial Distribution

  • 10816862023906 ()
  • 00816862023909 ()
  • 00816862023916 ()


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

  • 10816862021537 ()
  • 00816862021530 ()
  • 00816862028539 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC with 3 AD (OX,SG,pH)
WONDFO USA CO., LTD.
WDOA-254A-A3
In Commercial Distribution

  • 10816862021315 ()
  • 00816862021318 ()
  • 00816862028317 ()


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

  • 10816862026471 ()
  • 00816862026474 ()
  • 00816862026467 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 00816862025927 ()
TDOA-3135

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

  • 00816862025859 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7104A3
In Commercial Distribution

  • 00816862025309 ()
TDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 00816862025187 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 00816862025101 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact;AMP500,BAR,BUP,BZO,COC150,MDMA,MET500,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
CDOA-L6125
In Commercial Distribution

  • 10816862023616 ()
  • 00816862023619 ()
  • 00816862023626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel T-Square no THC with Indicator; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-496NTEUO-I
In Commercial Distribution

  • 10816862023456 ()
  • 00816862023459 ()
  • 00816862023466 ()
QODOA-496NTEUO-I

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

  • 00816862022407 ()
  • 00816862022384 ()
  • 00816862022391 ()


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

  • 00816862021219 ()
  • 00816862028218 ()
  • 10816862021216 ()


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