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,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7125A3
In Commercial Distribution

  • 10816862020325 ()
  • 00816862020328 ()
  • 00816862029321 ()
TDOA-7125A3

  • 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 with 3 AD*
WONDFO USA CO., LTD.
TDOA-6125A3
In Commercial Distribution

  • 10816862020264 ()
  • 00816862020267 ()
  • 00816862029260 ()
TDOA-6125A3

  • 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 with 3 AD*
WONDFO USA CO., LTD.
TDOA-6124A3
In Commercial Distribution

  • 10816862020240 ()
  • 00816862020243 ()
  • 00816862029246 ()
TDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C1012A-3A
Not in Commercial Distribution

  • 00816555020260 ()
C-C1012A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Square with indicator; 25 per box; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
DQODOA-10106EUO-I-25BX-A
In Commercial Distribution

  • 10816862023845 ()
  • 00816862023848 ()
  • 00816862023855 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-3104A3
In Commercial Distribution

  • 10816862026570 ()
  • 00816862026573 ()
  • 00816862026566 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
CDOA-1144
In Commercial Distribution

  • 10816862026518 ()
  • 00816862026511 ()
  • 00816862026504 ()


  • 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 with Vacu Lid
WONDFO USA CO., LTD.
TDOA-6125V
In Commercial Distribution

  • 00816862025842 ()
TDOA-6125V

  • 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 with 3 AD*
WONDFO USA CO., LTD.
TDOA-7125A3
In Commercial Distribution

  • 00816862025323 ()
TDOA-7125A3

  • 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 with 3 AD*
WONDFO USA CO., LTD.
TDOA-6125A3
In Commercial Distribution

  • 00816862025262 ()
TDOA-6125A3

  • 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 with 3 AD*
WONDFO USA CO., LTD.
TDOA-6124A3
In Commercial Distribution

  • 00816862025248 ()
TDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC,5 per box
WONDFO USA CO., LTD.
DWDOA-7125-5BX-A
In Commercial Distribution

  • 10816862024439 ()
  • 00816862024432 ()
  • 00816862024449 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP1000,BAR,BUP,BZO,COC300,EDDP,mAMP1000,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-2145
In Commercial Distribution

  • 10816862024200 ()
  • 00816862024203 ()
  • 00816862024210 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DTDOA-6125-2BX-A
In Commercial Distribution

  • 10816862023746 ()
  • 00816862023749 ()
  • 00816862023756 ()


  • 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 with 3AD
WONDFO USA CO., LTD.
CDOA-L6125A3
In Commercial Distribution

  • 10816862023630 ()
  • 00816862023633 ()
  • 00816862023640 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DTDOA-6125-2BX-A
In Commercial Distribution

  • 10816862023562 ()
  • 00816862023565 ()
  • 00816862023572 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, THC
WONDFO USA CO., LTD.
PRE-PDOA-4144
In Commercial Distribution

  • 10816862021841 ()
  • 00816862021844 ()
  • 00816862021851 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7110-22
In Commercial Distribution

  • M90107RD7110220 ()

  • Length: 74 Millimeter
07RD7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Chemtrue DOA Cup, AMP/COC/MET500/OPI300/OXY/PCP/THC + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
712G07A-CT
In Commercial Distribution

  • 00812203030483 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
CHEMTRON BIOTECH INC
PCA-14MP3-LC
In Commercial Distribution

  • 00812203030315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
CHEMTRON BIOTECH INC
712N04-G
In Commercial Distribution

  • 00812203030186 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 11, THC/COC/MOR/MET/AMP/BZO/BAR/MTD/BUP/MDMA/OXY, 25 tests/kit
CHEMTRON BIOTECH INC
C-61130D
In Commercial Distribution

  • 00812203030063 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, AMP/COC/MET/OPI2000/THC /A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712E04A
In Commercial Distribution

  • 00812203030018 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004001
In Commercial Distribution

  • 06977469280011 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004005
In Commercial Distribution

  • 06977469280004 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 30810038631364 ()
  • 00810038631363 ()
  • 10810038631360 ()
ECDOA-7124-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
EASY HEALTHCARE CORPORATION
EDOAP-3104
In Commercial Distribution

  • 10810038630622 ()
  • 00810038630625 ()
  • 30810038630626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 10810038631353 ()
  • 00810038631356 ()
  • 30810038631357 ()
ECDOA-7124-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
IDUN SOLUTIONS LLC
12511105000034
In Commercial Distribution

  • 90857275007813 ()


  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
SAFElife 10-Panel T-Cup Compact; 25 per box; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
DCDOA-8105-25BX-A
In Commercial Distribution

  • 10816862027362 ()
  • 00816862027365 ()
  • 00816862027358 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SAFElife 10-Panel T-Cup Compact; 25 per box; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
DCDOA-564-5BX-A
In Commercial Distribution

  • 10816862026655 ()
  • 00816862026658 ()
  • 00816862026641 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1P29-25
In Commercial Distribution

  • 00722066000847 ()
  • 00722066004029 ()
D10.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.12-1P29-25
In Commercial Distribution

  • 00722066003657 ()
  • 00722066004036 ()
D10.12-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC +AD
MERGERS MARKETING, INC.
PSC-DOA-264AD
In Commercial Distribution

  • 10850557007499 ()
  • 00850557007492 ()
  • 00850557007485 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Eight Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | MOR | MTD | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-284
In Commercial Distribution

  • 00850557007201 ()
  • 00850557007218 ()
  • 10850557007215 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP
EASY HEALTHCARE CORPORATION
EDOAP-6125B
In Commercial Distribution

  • 10850253007939 ()
  • 00850253007932 ()
  • 30850253007933 ()
EDOAP-6125B-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-6125B
In Commercial Distribution

  • 10850253007588 ()
  • 00850253007581 ()
  • 30850253007582 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-6125B
In Commercial Distribution

  • 10850253007571 ()
  • 00850253007574 ()
  • 30850253007575 ()


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