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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7-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-274
In Commercial Distribution

  • 00816862025163 ()
TDOA-274

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

  • 10816862020585 ()
  • 00816862020588 ()
  • 00816862029581 ()
WDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-264
In Commercial Distribution

  • 10816862020011 ()
  • 00816862020014 ()
  • 00816862029017 ()
KDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup Compact; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
CDOA-264
In Commercial Distribution

  • 10816862026419 ()
  • 00816862026412 ()
  • 00816862026405 ()


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

  • 00816862025583 ()
WDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-264
In Commercial Distribution

  • 00816862025019 ()
KDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square with indicator; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
QODOA-256EUO-I
In Commercial Distribution

  • 10816862022855 ()
  • 00816862022858 ()
  • 00816862022865 ()
QODOA-256EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square with indicator; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
DQODOA-256EUO-I-25BX-A
In Commercial Distribution

  • 10816862022657 ()
  • 00816862022650 ()
  • 00816862023602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup Compact; BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-564
In Commercial Distribution

  • 00816862022087 ()
  • 00816862022094 ()
  • 10816862022084 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cube; AMP,COC,MET,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
ODOA-376EUO
In Commercial Distribution

  • 10816862022022 ()
  • 00816862022025 ()
  • 00816862022032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Strips; THC Marijuana/Cannabinoids Test Retail Box 10 Pcs
WONDFO USA CO., LTD.
WDTH114-10BX
In Commercial Distribution

  • 10816862021964 ()
  • 00816862021967 ()
  • 00816862021974 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Preview Dip Card; AMP, COC, mAMP, OPI, THC
WONDFO USA CO., LTD.
PRE-WDOA-254
In Commercial Distribution

  • 10816862021452 ()
  • 00816862021455 ()
  • 00816862028454 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-254A
In Commercial Distribution

  • 10816862021254 ()
  • 00816862021257 ()
  • 00816862028256 ()


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

  • 10816862020165 ()
  • 00816862020168 ()
  • 00816862029161 ()
TDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SSB-148
In Commercial Distribution

  • 00816036029003 ()
  • 00816036028501 ()
SSB-148

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2-Panel STATDIP CLIA WAIVED Dipcard, COC/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-124-0
In Commercial Distribution

  • 00816036025654 ()
  • 00816036026132 ()
SDP-124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen-5 COC/M-AMP/MOP(300)/BZO/THC
JANT PHARMACAL CORPORATION
DS134AC425
In Commercial Distribution

  • 10763924134424 ()
  • 00763924134427 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen 5-panel (AMP/COC/PCP/OPI/THC)
JANT PHARMACAL CORPORATION
DS61AC425
In Commercial Distribution

  • 10763924061423 ()
  • 00763924061426 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Clia Cup COC/THC/OPI/AMP/mAMP
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-254
In Commercial Distribution

  • 00895330002806 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
6 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-264
In Commercial Distribution

  • 00895330002721 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 4 Panel COC/OPI/mAMP/THC
RITE AID CORPORATION
8024510
In Commercial Distribution

  • 00011822001663 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
DOA Single Test Dipcard, 25Pcs/Box Clia Waived THC
W.H.P.M. INC.
WTH-25-FS
In Commercial Distribution

  • 00841824103177 ()
  • 00841824103184 ()
WTH-25-FS

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
DOA Single Test Dipcard, 25Pcs/Box Clia Waived THC
W.H.P.M. INC.
WTH-25
In Commercial Distribution

  • 00841824100602 ()
  • 00841824101821 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 3 THC / COC / OPI
Siemens Healthcare Diagnostics Inc.
10445358
In Commercial Distribution

  • 00842768001291 ()
  • 00630414013916 ()
6A179UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel Test Card AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-254L
In Commercial Distribution

  • 20817038021143 ()
  • 10817038021146 ()
  • 00817038021149 ()
U-DOA-254L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/mAMP/THC)
ALERE SAN DIEGO, INC.
DOA-234
In Commercial Distribution

  • 10815845020581 ()
  • 00815845020584 ()
4012090099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/AMP/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020177
In Commercial Distribution

  • 10858904006355 ()
  • 00858904006358 ()
DOA-174-721

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/BZO/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020176
In Commercial Distribution

  • 10858904006348 ()
  • 00858904006341 ()
DOA-174-711

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC One Step Marijuana Single Drug Test (Urine) (THC50)
ALERE SAN DIEGO, INC.
DTH-114
In Commercial Distribution

  • 10815845020314 ()
  • 00815845020317 ()
4012390099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi Drug Screen Test -THC,COT(15tests one kit)
EASY HEALTHCARE CORPORATION
EDOAP-124
In Commercial Distribution

  • 10810038634118 ()
  • 00810038634111 ()
  • 30810038634112 ()
EDOAP-124-15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80622
Not in Commercial Distribution

  • B313OT806221 ()
  • B313OT806220 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80605
Not in Commercial Distribution

  • B313OT806051 ()
  • B313OT806050 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80602
Not in Commercial Distribution

  • B313OT806021 ()
  • B313OT806020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox Device - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80509
Not in Commercial Distribution

  • B313OT805091 ()
  • B313OT805090 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Test Card COC/THC/OPI/AMP/BZO
UCP BIOSCIENCES, INC.
UCD-5-1-CLIA
In Commercial Distribution

  • 20817038020795 ()
  • 10817038020798 ()
  • 00817038020791 ()
UCD-5-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Test Cup COC/THC/MET/OPI/AMP
UCP BIOSCIENCES, INC.
U-CUP-254-RCLN
In Commercial Distribution

  • 20817038020719 ()
  • 10817038020712 ()
  • 00817038020715 ()
U-CUP-254-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BAR300/BZO300/COC300/MET1000/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA06111 ()
  • B115ABCUPA06110 ()


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

  • B115ABCUPA06091 ()
  • B115ABCUPA06090 ()
ABCupA-06-09

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

  • B115ABCUPA06081 ()
  • B115ABCUPA06080 ()
ABCupA-06-08

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

  • B115ABCUPA06041 ()
  • B115ABCUPA06040 ()
ABCupA-06-04

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