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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DOA 5 in 1 Test Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WCUP254 W/AD
In Commercial Distribution

  • 00841824101661 ()
  • 00841824101289 ()
WCUP254 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
WCUP1104
In Commercial Distribution

  • 00841824101197 ()
  • 00841824101555 ()
WCUP1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived BZO/COC/mAMP/OPI/OXY/THC
W.H.P.M. INC.
ECOⅡ-564
In Commercial Distribution

  • 00841824101135 ()
  • 00841824101494 ()
ECOⅡ-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/THC
W.H.P.M. INC.
ECOⅡ-264
In Commercial Distribution

  • 00841824101128 ()
  • 00841824101487 ()
ECOⅡ-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
WHPM DOA Push Button 5 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC
W.H.P.M. INC.
WCUP254
In Commercial Distribution

  • 00841824100909 ()
  • 00841824101296 ()
WCUP254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck NxStep OnSite Drug Test - AMP BUP BZO COC MTD OPI300 OXY THC & pH SG OX CR NI
Express Diagnostic Int'l, Inc.
60890-5
In Commercial Distribution

  • B2986089051 ()
60890-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET/MTD/MOR/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712M08-G
In Commercial Distribution

  • 00812203030858 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
PCU-13FCW-25
In Commercial Distribution

  • 00812203030773 ()
PCU-13FCW-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue 7-Panel DOA Dip Card, BZO/COC150/MET500/MOR/OXY/PCP/THC (Ni/pH/Gl)(Cr/SG/Ox)
CHEMTRON BIOTECH INC
711G05A-CT
In Commercial Distribution

  • 00812203030513 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH)
CHEMTRON BIOTECH INC
712L16A-G
In Commercial Distribution

  • 00812203030261 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/PPX/THC (Cr/SG/Bl)
CHEMTRON BIOTECH INC
712L15A-G
In Commercial Distribution

  • 00812203030216 ()


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

  • 00816036027108 ()
  • 00816036026606 ()
SCP-6167-0-A

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

  • 00816036026545 ()
  • 00816036027047 ()
SCP-2167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BUP/BZO/COC/MAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-2114-0
In Commercial Distribution

  • 00816036025913 ()
  • 00816036026392 ()
SDP-2114-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 8 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR//THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STAII-3187-0
In Commercial Distribution

  • 00816036025449 ()
  • 00816036025432 ()
STATII-3187-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0
In Commercial Distribution

  • 00816036025104 ()
  • 00816036025265 ()
STATⅡ-41107-0

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

  • 00816036025098 ()
  • 00816036025258 ()
STATⅡ-21107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST LABS DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
FST-4267
In Commercial Distribution

  • 00816036021878 ()
  • 00816036021885 ()
FST-4267

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATⅡ-4267
In Commercial Distribution

  • 00816036021793 ()
  • 00816036021809 ()
STATⅡ-4267

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/EDDP/MOR/MTD/THC
MICRO DISTRIBUTING, L.C
STATⅡ-3167
In Commercial Distribution

  • 00816036021748 ()
  • 00816036021755 ()
STATⅡ-3167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/PCP/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-1387-A
In Commercial Distribution

  • 00816036021335 ()
  • 00816036021519 ()
SCP-1387-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 7 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/OXY/THC+pH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2277-A
In Commercial Distribution

  • 00816036021328 ()
  • 00816036021502 ()
SCP-2277-A

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

  • 00816036021236 ()
  • 00816036021410 ()
SCP-1247-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3
In Commercial Distribution

  • 00816036020826 ()
  • 00816036021038 ()
STATⅡ-2167-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 7 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BZO/COC/mAMP/MDMA/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-174
In Commercial Distribution

  • 00816036020147 ()
  • 00816036020697 ()
SDP-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(COC/THC)+(MET/OPI)+(PCP/AMP)+BAR+BZO+MTD+OXY with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10MO
Not in Commercial Distribution

  • 00816565021516 ()
IMCA-10MO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immutest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMDA-9AMJ
Not in Commercial Distribution

  • 00816565021318 ()
IMDA-9AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/PCP/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D11.3-1P29-25
In Commercial Distribution

  • 00722066003664 ()
  • 00722066004050 ()
D11.3-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.6-1P29-25
In Commercial Distribution

  • 00722066003312 ()
  • 00722066004043 ()
D10.6-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.6-1G29-25
In Commercial Distribution

  • 00722066003107 ()
  • 00722066004142 ()
D10.6-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MDMA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Phencyclidine, Barbiturates, Benzodiazepines, Methadone, 3,4-Methylenedioxy-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.3-1G29-25
In Commercial Distribution

  • 00722066000915 ()
  • 00722066004135 ()
D10.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1G29-25
In Commercial Distribution

  • 00722066000908 ()
  • 00722066004128 ()
D10.1-1G29

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC-COOH 1000 NG/ML
UTAK LABORATORIES, INC.
THC 1000 U F SDHL
In Commercial Distribution

  • B800THC1000UFSDHL5 ()
  • B800THC1000UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 1000 U F SDHL

  • Multiple drugs of abuse IVD, control
THC-COOH 25 NG/ML
UTAK LABORATORIES, INC.
THC 25 U F SDHL
In Commercial Distribution

  • B800THC25UFSDHL5 ()
  • B800THC25UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 25 U F SDHL

  • Multiple drugs of abuse IVD, control
No Description
Clinical Guard
THC Marijuana Drug Test Strip
In Commercial Distribution

  • 00851950008123 ()
  • 00851950008062 ()
  • 10851950008120 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-Drug of Abuse Urine Cup Test AMP BAR BUP BZD COC MET MOR300 MTD OXY PCP TCA THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4680
In Commercial Distribution

  • 00796918002440 ()
  • 10796918002447 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP COC MET MOR PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4703OT
In Commercial Distribution

  • 10796918002065 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD PCP TCA THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4570
In Commercial Distribution

  • 10796918001518 ()
  • 00796918001511 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET, MOR, MTD, PCP, PPX, TCA, THC, XTC wADU
ALFA SCIENTIFIC DESIGNS, INC.
03-3957
In Commercial Distribution

  • 10796918001433 ()
  • 00796918001436 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST - 6 Drug Cup (urine strip cup) AMP (1000), COC (300), OPI (2000), MET (1000), THC (50), PCP (25)
JANT PHARMACAL CORPORATION
DS87S625
In Commercial Distribution

  • 10763924087539 ()
  • 00763924087532 ()


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