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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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Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/OPI/BZO) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, THC and Cocaine metabolites in urine.
BTNX Inc
D6.1-1P29-25
In Commercial Distribution

  • 00722066000830 ()
  • 00722066004005 ()
D6.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers. The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0152-5
In Commercial Distribution

  • 00811727017338 ()
60-TH0152-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Rapid Response Multi Drug Integrated Split Specimen Cup (COC/MET/THC/OPI/PCP) - 25 tests/ kit are for the qualitative detection of Methamphetamine, Opiates, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D5.3-1G29-25
In Commercial Distribution

  • 00722066000885 ()
  • 00722066004104 ()
D5.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, OPI, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5230
In Commercial Distribution

  • 00847817000393 ()
1945230

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000392 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000361 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
60960D
Not in Commercial Distribution

  • 00859144006153 ()
60960D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
Instant Tech Subsidiary Acquisition
PSCup-10CT
Not in Commercial Distribution

  • 00858998006975 ()
PSCup-10CT

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