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/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA14011 ()
  • B115ABCARDA14010 ()
ABCardA-14-01

  • 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
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0
In Commercial Distribution

  • 00816036027160 ()
  • 00816036026668 ()
SCP-31107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0-A
In Commercial Distribution

  • 00816036027092 ()
  • 00816036026590 ()
SCP-6157-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0
In Commercial Distribution

  • 00816036026552 ()
  • 00816036027054 ()
SCP-21107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0-A
In Commercial Distribution

  • 00816036026538 ()
  • 00816036027030 ()
SCP-3257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, 25Pcs/Box AMP/COC/mAMP/OPI/THC + CR,OX,pH
MICRO DISTRIBUTING, L.C
SCP-1257-0-A
In Commercial Distribution

  • 00816036026514 ()
  • 00816036027016 ()
SCP-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-9104-0
In Commercial Distribution

  • 00816036025890 ()
  • 00816036026378 ()
SDP-9104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BUP/BZO/COC/MAMP/MDMA/MOR/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-8104-0
In Commercial Distribution

  • 00816036025883 ()
  • 00816036026361 ()
SDP-8104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-6104-0
In Commercial Distribution

  • 00816036025876 ()
  • 00816036026354 ()
SDP-6104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/OPI/MDMA/MTD/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-4104-0
In Commercial Distribution

  • 00816036025845 ()
  • 00816036026323 ()
SDP-4104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MTD/OPI/PCP/TCA/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1104-0
In Commercial Distribution

  • 00816036025838 ()
  • 00816036026316 ()
SDP-1104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard w/AD, COC/MAMP/OPI/PCP/THC + pH,CR,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-354-0-A
In Commercial Distribution

  • 00816036025715 ()
  • 00816036026194 ()
SDP-354-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-6167-0-A
In Commercial Distribution

  • 00816036025050 ()
  • 00816036025227 ()
STATⅡ-6167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0-A
In Commercial Distribution

  • 00816036025043 ()
  • 00816036025210 ()
STATⅡ-2167-3-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Dipcard, 25Pcs/Box BUP/BZO/COC/MOR/MTD/THC
MICRO DISTRIBUTING, L.C
SDP-464
In Commercial Distribution

  • 00816036021786 ()
  • 00816036021793 ()
SDP-464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Cup,25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-2167
In Commercial Distribution

  • 00816036021298 ()
  • 00816036021472 ()
SCP-2167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-1257
In Commercial Distribution

  • 00816036020802 ()
  • 00816036021014 ()
STATⅡ-1257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-6257
In Commercial Distribution

  • 00816036020796 ()
  • 00816036021007 ()
STATⅡ-6257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-164
In Commercial Distribution

  • 00816036020260 ()
  • 00816036020642 ()
SDP-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST - 5 Drug Test Cup *CLIA-Waived* AMP (1000), COC (300), OPI (2000), PCP (25), and THC (50)
JANT PHARMACAL CORPORATION
DS86S625
In Commercial Distribution

  • 10763924086532 ()
  • 00763924086535 ()


  • 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
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
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-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
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
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
Chemtrue 10-Panel DOA Dip Card, AMP/BAR/BZO/COC/MET/MTD/OPI2000/OXY/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
711J10-CT
In Commercial Distribution

  • 00850019007732 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup Test- AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L01G
In Commercial Distribution

  • 00850019007671 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Methamphetamine (mAMP), Marijuana (THC),
GERMAINE LABORATORIES, INC
40325
In Commercial Distribution

  • 00695684403256 ()
  • 00695684403251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine 300 (COC 300) & Marijuana (THC).
GERMAINE LABORATORIES, INC
40225
In Commercial Distribution

  • 00695684402259 ()
  • 00695684402251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-61103D
Not in Commercial Distribution

  • 00859144006047 ()
C-61103D

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