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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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-01
In Commercial Distribution

  • M90107RD7064011 ()
  • M90107RD7064010 ()

  • Length: 75 Millimeter
07RD7064-01

  • 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
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445116
In Commercial Distribution

  • 00842768015441 ()
  • 00630414004891 ()
K5095

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
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
No Description
Clinical Guard
THC Marijuana Drug Test Strip
In Commercial Distribution

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


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
CSC-8104
In Commercial Distribution

  • 00850557007942 ()
  • 00850557007959 ()
  • 10850557007956 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-4104
In Commercial Distribution

  • 00850557007928 ()
  • 00850557007935 ()
  • 10850557007932 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
CSC-3104
In Commercial Distribution

  • 00850557007904 ()
  • 00850557007911 ()
  • 10850557007918 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
PSC-DOA-8104
In Commercial Distribution

  • 00850557007669 ()
  • 00850557007676 ()
  • 10850557007673 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7104
In Commercial Distribution

  • 00850557007621 ()
  • 00850557007638 ()
  • 10850557007635 ()


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