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 (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
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
Four Drug PreScreen Plus (CLIA Waived) Dip Card Combo: COC|MET|THC|OPI
MERGERS MARKETING, INC.
PS-DOA-144
In Commercial Distribution

  • 10851000007295 ()
  • 00851000007298 ()
  • 00851000007281 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Multi-Drug Screen Test ; THC,COC,OPI,AMP,PCP (25 tests kit)
EASY HEALTHCARE CORPORATION
EDOAP-154
In Commercial Distribution

  • 10855944007632 ()
  • 00855944007635 ()
  • 30855944007636 ()
EDOAP-154-25

  • 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
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
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
THC, COC, OPI, MET, BZO, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-60650D
Not in Commercial Distribution

  • 00859144006009 ()
C-60650D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
Instant Tech Subsidiary Acquisition
PSD-8BUP
Not in Commercial Distribution

  • 00858998006906 ()
PSD-8BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+THC
Instant Tech Subsidiary Acquisition
PSD-8P
Not in Commercial Distribution

  • 00858998006913 ()
PSD-8P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, PCP, OPI, MET drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60610N
In Commercial Distribution

  • 00858984006101 ()
C-60610N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
MEDICAL DISTRIBUTION GROUP INC
ID-US1-DIP-THC
In Commercial Distribution

  • 00850013035137 ()
  • 10850013035134 ()
ID-US1-DIP-THC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO
UCP BIOSCIENCES, INC.
U-CUP-654
In Commercial Distribution

  • 20817038022225 ()
  • 10817038022228 ()
  • 00817038022221 ()
U-CUP-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/OPI
UCP BIOSCIENCES, INC.
U-DOA-254
In Commercial Distribution

  • 20817038022140 ()
  • 10817038022143 ()
  • 00817038022146 ()
U-DOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/BZO
UCP BIOSCIENCES, INC.
U-DOA-654
In Commercial Distribution

  • 20817038022133 ()
  • 10817038022136 ()
  • 00817038022139 ()
U-DOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AYDMED Rapid Multi-Drug Test Dip Card (AMP/BZO/COC/MDMA/MTD/OPI/THC)
UCP BIOSCIENCES, INC.
DOA-3174-061
In Commercial Distribution

  • 20817038022096 ()
  • 10817038022099 ()
  • 00817038022092 ()
DOA-3174-061

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-CardTM Drug Test Screen 5 Panel Test Card AMP/COC/THC/MET/BZO
UCP BIOSCIENCES, INC.
U-DOA-654
In Commercial Distribution

  • 20817038022058 ()
  • 10817038022051 ()
  • 00817038022054 ()
U-DOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AIDTEQ Rapid Multi-Drug Test Dip Card (AMP/BZO/COC/MDMA/MTD/OPI/THC)
UCP BIOSCIENCES, INC.
DOA-3174-061
In Commercial Distribution

  • 10817038022020 ()
  • 00817038022023 ()
  • 20817038022027 ()
DOA-3174-061

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen 5 panel Test Card(AMP/COC/OPI/PCP/THC)
UCP BIOSCIENCES, INC.
U-DOA-154L
In Commercial Distribution

  • 20817038021853 ()
  • 10817038021856 ()
  • 00817038021859 ()
U-DOA-154L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-284
In Commercial Distribution

  • 10817038021337 ()
  • 00817038021330 ()
  • 20817038021334 ()
U-CUP-284

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Test Cup AMP/BZO/COC/MET/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-184
In Commercial Distribution

  • 20817038021327 ()
  • 10817038021320 ()
  • 00817038021323 ()
U-CUP-184

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC150/AMP300/MAMP500/BAR/BZO/OPI300/MDMA/OXY/PCP/MTD/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020187
In Commercial Distribution

  • 10858904006454 ()
  • 00858904006457 ()
DOA-1114-131

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/PPX/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020186
In Commercial Distribution

  • 10858904006447 ()
  • 00858904006440 ()
DOA-1114-121

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104
In Commercial Distribution

  • 00895330002738 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/BAR/OXY/MDMA/PPX
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-2104
In Commercial Distribution

  • 00895330002714 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THC, 5 tests
ALFA SCIENTIFIC DESIGNS, INC.
03-3577OT-5
In Commercial Distribution

  • 10796918002133 ()
  • 00796918002136 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MOR300, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3764
In Commercial Distribution

  • 10796918002089 ()
  • 00796918002082 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3761QW
In Commercial Distribution

  • 10796918002041 ()
  • 00796918002044 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MOR300 THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4437-50
In Commercial Distribution

  • 10796918002034 ()
  • 00796918002037 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4429
In Commercial Distribution

  • 10796918001853 ()
  • 00796918001856 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MOR, MTD, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6760QW
In Commercial Distribution

  • 10796918001709 ()
  • 00796918001702 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, COC, MET, MOR300, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3766
In Commercial Distribution

  • 10796918001273 ()
  • 00796918001276 ()


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