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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SYNCHRON Systems 125 ng/mL THC Urine Control
Beckman Coulter, Inc.
465939
In Commercial Distribution

  • 15099590228743 ()
465939

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 75 ng/mL THC Urine Control
Beckman Coulter, Inc.
465912
In Commercial Distribution

  • 15099590227258 ()
465912

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 20 ng/mL THC Urine Control
Beckman Coulter, Inc.
465914
In Commercial Distribution

  • 15099590227234 ()
465914

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 200 ng/mL THC Urine Calibrator
Beckman Coulter, Inc.
445814
In Commercial Distribution

  • 15099590224868 ()
445814

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
SYNCHRON Systems 10 ng/mL THC Urine Control
Beckman Coulter, Inc.
472107
In Commercial Distribution

  • 15099590223434 ()
472107

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 40 ng/mL THC Urine Control
Beckman Coulter, Inc.
472110
In Commercial Distribution

  • 15099590223427 ()
472110

  • Cannabinoid/cannabinoid metabolite IVD, control
5 tests kit;Marijuana Test Strip(THC 20)
EASY HEALTHCARE CORPORATION
ESTH-215
In Commercial Distribution

  • 10810038638093 ()
  • 00810038638096 ()
  • 20810038638090 ()
ESTH-215-5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Rapid Response Single Drug Test Strips (THC) - 100 tests/ kit are for the qualitative detection of THC metabolite in urine.
BTNX Inc
THC-1S13-100
In Commercial Distribution

  • 00722066000724 ()
  • 00722066003893 ()
THC-1S13-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/THC) are for the qualitative detection of Cocaine and THC metabolites in urine.
BTNX Inc
D2.1-1P29-25
In Commercial Distribution

  • 00722066000762 ()
  • 00722066003947 ()
D2.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassette (THC) - 40 tests/ kit are for the qualitative detection of THC metabolite in urine.
BTNX Inc
THC-1C13-40
In Commercial Distribution

  • 00722066000731 ()
  • 00722066003886 ()
THC-1C13-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC
BIOTECH SCREENING LLC
CI-575
In Commercial Distribution

  • 00863112000364 ()
CI-575

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC
BIOTECH SCREENING LLC
CINM-774
In Commercial Distribution

  • 10863112000323 ()
  • 00863112000326 ()
  • 00863112000357 ()
CINM-774

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC
BIOTECH SCREENING LLC
CINM-274
In Commercial Distribution

  • 10863112000316 ()
  • 00863112000319 ()
  • 00863112000333 ()
CINM-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
K2 Synthetic THC, JWH-018 5-PENTANOIC ACID URINE CONTROL KITBOX
BIOCHEMICAL DIAGNOSTICS INC
702017
In Commercial Distribution

  • 00850004812181 ()
702017

  • Multiple drugs of abuse IVD, control
DrugSmart Dip 4, AMP/COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30450D
In Commercial Distribution

  • 00850019007053 ()
30450D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 3, MET/COC/THC, 25 tests/kit
CHEMTRON BIOTECH INC
30300D
In Commercial Distribution

  • 00850019007749 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Drug Tested Home Drug Test (THC) 2 Pack
CONFIRM BIOSCIENCES, INC.
CB-DC-1PANELOTCPACK2
In Commercial Distribution

  • 10856464008505 ()
  • 00856464008508 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
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
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
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
AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD09031 ()
  • B115ABCARD09030 ()
ABCard-09-03

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

  • B115ABCUP09031 ()
  • B115ABCUP09030 ()
ABCup-09-03

  • 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

  • B115ABCARDA06111 ()
  • B115ABCARDA06110 ()
ABCardA-06-11

  • 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

  • B115ABCARDA06091 ()
  • B115ABCARDA06090 ()
ABCardA-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

  • B115ABCARDA06081 ()
  • B115ABCARDA06080 ()
ABCardA-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

  • B115ABCARDA06041 ()
  • B115ABCARDA06040 ()
ABCardA-06-04

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

  • B115ABCARDA06011 ()
  • B115ABCARDA06010 ()
ABCardA-06-01

  • 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
AMP/BZO/COC/MET/MOR/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA06011 ()
  • B115ABCUPA06010 ()
ABCupA-06-01

  • 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
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
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 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
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
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
5 panel test cup, AMP/COC/MET1000/OPI2000/THC
AMEDITECH INC.
IMC-5M
Not in Commercial Distribution

  • 00816565020144 ()
IMC-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO/COC/MET1000/OPI300/THC
AMEDITECH INC.
IMC-5MB300
Not in Commercial Distribution

  • 00816565020151 ()
IMC-5MB300

  • 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
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
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7010
In Commercial Distribution

  • M90107RD70101 ()
  • M90107RD70100 ()

  • Length: 75 Millimeter
07RD7010

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7009
In Commercial Distribution

  • M90107RD70091 ()
  • M90107RD70090 ()

  • Length: 75 Millimeter
07RD7009

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