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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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Pointe Cannabinoids (THC) Calibrator (25 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.
POINTE SCIENTIFIC, INC.
60-TH0146-5
In Commercial Distribution

  • 00811727017284 ()
60-TH0146-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Calibrator (200 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.
POINTE SCIENTIFIC, INC.
60-TH0158-5
In Commercial Distribution

  • 00811727017376 ()
60-TH0158-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Calibrator (50 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.
POINTE SCIENTIFIC, INC.
60-TH0150-5
In Commercial Distribution

  • 00811727017307 ()
60-TH0150-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Calibrator (12.5 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.
POINTE SCIENTIFIC, INC.
60-TH0144-5
In Commercial Distribution

  • 00811727017277 ()
60-TH0144-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Rapid Response Multi Drug Test Panels (COC/AMP/MET/OPI/THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, THC and Cocaine metabolites in urine.
BTNX Inc
D5.1-1P29-25
In Commercial Distribution

  • 00722066000809 ()
  • 00722066003992 ()
D5.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RTC II cup with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA in Bulk RTC II 1st Generation with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA
AMERICAN BIO MEDICA CORPORATION
10-8MZX2AB-030
In Commercial Distribution

  • 10694644200475 ()
  • 10694644250470 ()
10-8MZX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI2000, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5183
In Commercial Distribution

  • 00847817000799 ()
1945183

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5209
In Commercial Distribution

  • 00847817000607 ()
1945209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5182
In Commercial Distribution

  • 00847817000348 ()
1945182

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR CDOA261
In Commercial Distribution

  • 20850011007031 ()
  • 10850011007034 ()
  • 00850011007037 ()
TNR CDOA261

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
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