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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CASSETTE 06 (6 Drug AMP/COC/THC/M-AMP/OPI2/PCP) [CLIA Waived]
REDWOOD TOXICOLOGY LABORATORY, INC.
011020166
In Commercial Distribution

  • 10858904006003 ()
  • 00858904006006 ()
DOA-1165-OBC-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Health Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
MEDICAL DISTRIBUTION GROUP INC
ID-H1-DIP-THC
In Commercial Distribution

  • 10850721007911 ()
  • 00850721007914 ()
ID-H1-DIP-THC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007871 ()
  • 10850721007874 ()
  • 00850721007877 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ25
In Commercial Distribution

  • 20850721007710 ()
  • 10850721007713 ()
  • 00850721007716 ()
ID-THC-DIP-AZ25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ10
In Commercial Distribution

  • 20850721007598 ()
  • 10850721007591 ()
  • 00850721007594 ()
ID-THC-DIP-AZ10

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007475 ()
  • 10850721007478 ()
  • 00850721007471 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ5
In Commercial Distribution

  • 20850721007468 ()
  • 10850721007461 ()
  • 00850721007464 ()
ID-THC-DIP-AZ5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-664-RCN
In Commercial Distribution

  • 20850721007116 ()
  • 10850721007119 ()
  • 00850721007112 ()
U-CUP-664-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MGC HEALTH™ D-PEN™ MINI THC ORAL FLUID TEST, 2T/Box
Guangzhou Decheng Biotechnology Co., LTD
2T
In Commercial Distribution

  • 30383173000253 ()
  • 00383173000252 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA09031 ()
  • B115ABCUPA09030 ()
ABCupA-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP12061 ()
  • B115ABCUP12060 ()
ABCup-12-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP12021 ()
  • B115ABCUP12020 ()
ABCup-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP12011 ()
  • B115ABCUP12010 ()
ABCup-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA09031 ()
  • B115ABCARDA09030 ()
ABCardA-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD12061 ()
  • B115ABCARD12060 ()
ABCard-12-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD12021 ()
  • B115ABCARD12020 ()
ABCard-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD12011 ()
  • B115ABCARD12010 ()
ABCard-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck SalivaScan Oral Fluid Drug Test, AMP COC MET OPI OXY THC
Express Diagnostic Int'l, Inc.
80617-EI
In Commercial Distribution

  • B29880617EI0 ()
80617-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB3, SS3-168 6-Panel SWAB (AMP/COC/MAMP/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SS3-168
In Commercial Distribution

  • 00816036028020 ()
  • 00816036027528 ()
SS3-168

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, BZO/COC/mAMP/MOR/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0
In Commercial Distribution

  • 00816036027146 ()
  • 00816036026644 ()
SCP-6157-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, COC/mAMP/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0
In Commercial Distribution

  • 00816036026521 ()
  • 00816036027023 ()
SCP-3257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-1257-0
In Commercial Distribution

  • 00816036026507 ()
  • 00816036027009 ()
SCP-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard, BZO/COC/MAMP/MOR/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-654-0
In Commercial Distribution

  • 00816036025739 ()
  • 00816036026217 ()
SDP-654-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-354-0
In Commercial Distribution

  • 00816036025708 ()
  • 00816036026187 ()
SDP-354-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard, AMP/COC/MAMP/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-254-0
In Commercial Distribution

  • 00816036025692 ()
  • 00816036026170 ()
SDP-254-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/MDMA/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1554-0
In Commercial Distribution

  • 00816036025685 ()
  • 00816036026163 ()
SDP-1554-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
JANT PHARMACAL CORPORATION
DS319
In Commercial Distribution

  • 10763924319913 ()
  • 00763924319916 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
ACCUTEST MD-10(AMP/BARB/BZD/COC/MTDN/M-AMP/MOP/PCP/TCA/THC)
JANT PHARMACAL CORPORATION
DS130AC425
In Commercial Distribution

  • 10763924130426 ()
  • 00763924130429 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest-5 Split Cup (AMP1000 /COC 300 / OPI 2000/ PCP 25/ THC 50)
JANT PHARMACAL CORPORATION
DS03AC625
In Commercial Distribution

  • 10763924003621 ()
  • 00763924003624 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest-5 Split Cup (AMP1000 /COC 300 /MET 1000/ OPI 2000/ THC 50)
JANT PHARMACAL CORPORATION
DS02AC625
In Commercial Distribution

  • 10763924002624 ()
  • 00763924002627 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 10810038630509 ()
  • 00810038630502 ()
  • 30810038630503 ()
EDOAP-264-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QSCREEN 4 Multi Test - COC 300, MET 1000, OPI 2000,THC 50
SYNTRON BIORESEARCH, INC.
60411
In Commercial Distribution

  • 20748349000339 ()
  • 10748349000332 ()
  • 00748349000335 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QuikScreen 4 Drug Cup - AMP 1000, COC 300, OPI 2000,THC 50
SYNTRON BIORESEARCH, INC.
60400
In Commercial Distribution

  • 20748349000209 ()
  • 00748349000205 ()
  • 10748349000202 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
SYNTRON BIORESEARCH, INC.
60505
In Commercial Distribution

  • 20748349000056 ()
  • 10748349000059 ()
  • 00748349000052 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable
No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable
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 (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
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 (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
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
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
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