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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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No Description
Microgenics Corporation
1661060
In Commercial Distribution

  • 00884883004870 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661086
In Commercial Distribution

  • 00884883004863 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661078
In Commercial Distribution

  • 00884883001954 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
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 (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
Pointe Cannabinoids (THC) Calibrator (150 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-TH0156-5
In Commercial Distribution

  • 00811727017369 ()
60-TH0156-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Calibrator (100 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-TH0154-5
In Commercial Distribution

  • 00811727017345 ()
60-TH0154-5

  • 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 (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
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
7-Panel DOA Dip Card THC/COC/MOR300/AMP/MET/BZO/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711G02JAJ
In Commercial Distribution

  • 00850019007572 ()
711G02JAJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screen Dip Card Tests, AMP/COC/OPI2000/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711E06
In Commercial Distribution

  • 00850019007329 ()
711E06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screen Dip Card Tests, AMP/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711E03
In Commercial Distribution

  • 00850019007305 ()
711E03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711C02CT
In Commercial Distribution

  • 00850019007282 ()
711C02CT

  • Y-piece breathing circuit connector, reusable
6-Panel Drug Screen Cup Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712F01
In Commercial Distribution

  • 00850019007039 ()
712F01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6 CLIA-Waived, THC/COC/OPI2K/MET/BZO/OXY, 25 tests/kit
CHEMTRON BIOTECH INC
C-60650D
In Commercial Distribution

  • 00850019007756 ()


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