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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25 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
EASY HEALTHCARE CORPORATION
EDOAP-3104
In Commercial Distribution

  • 30810038631371 ()
  • 00810038631370 ()
EDOAP-3104-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50
SYNTRON BIORESEARCH, INC.
60510
In Commercial Distribution

  • 20748349000117 ()
  • 10748349000110 ()
  • 00748349000113 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN Multi 5 Drug Cup Test – BUP 10, BZD 300, COC 300, OPI 2000, THC 50
SYNTRON BIORESEARCH, INC.
60568
In Commercial Distribution

  • 20748349000407 ()
  • 10748349000400 ()
  • 00748349000403 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN MULTI 5 DRUG CUP TEST - BZD 300, COC 300, MET 1000, OPI 300, THC 50
SYNTRON BIORESEARCH, INC.
60554
In Commercial Distribution

  • 20748349000285 ()
  • 10748349000288 ()
  • 00748349000281 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
PRIME SCREEN® Marijuana (THC) Urine Test Strip, 20 Tests per Box with Plastic Urine Cups
WONDFO USA CO., LTD.
DWDTH-101-20BX-CUP-A
In Commercial Distribution

  • 10816862027324 ()
  • 00816862027327 ()
  • 00816862027310 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
Five Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-254AD
In Commercial Distribution

  • 00850557007447 ()
  • 00850557007454 ()
  • 10850557007451 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Seven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-274
In Commercial Distribution

  • 00850557007188 ()
  • 00850557007195 ()
  • 10850557007192 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 10850253007564 ()
  • 00850253007567 ()
  • 30850253007568 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 10850253007557 ()
  • 00850253007550 ()
  • 30850253007551 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (100 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007529 ()
  • 30855944007520 ()
ACDOA-264-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (50 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007512 ()
  • 30855944007513 ()
ACDOA-264-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (25 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007505 ()
  • 30855944007506 ()
  • 10855944007502 ()
ACDOA-264-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (10 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007499 ()
  • 30855944007490 ()
ACDOA-264-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (5 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution

  • 00855944007253 ()
  • 30855944007254 ()
ACDOA-264-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test for the detection of Cannabinoids (THC) and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601584
Not in Commercial Distribution

  • 00690286000100 ()
  • 10690286000107 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/MDMA/MET500/MTD/MOR/OXY/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L11D
In Commercial Distribution

  • 00850019007978 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 11, AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP, 25tests/kit, CLIA-Waived
CHEMTRON BIOTECH INC
61127D
In Commercial Distribution

  • 00850019007688 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12, THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY, 25test/kit
CHEMTRON BIOTECH INC
61230D
In Commercial Distribution

  • 00850019007602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/COC/THC/OPI2000/MET/PCP/BAR/BZO/MTD/OXY - Clia Waived, 25tests/kit
CHEMTRON BIOTECH INC
C-61020D
In Commercial Distribution

  • 00850019007558 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Dip Card Test, AMP/BAR/BZO/COC/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
DOA4105
In Commercial Distribution

  • 00850019007534 ()
DOA4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12, THC/COC/MOR300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
C61213D
In Commercial Distribution

  • 00850019007503 ()
C61213D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/BAR/BZO/COC150/MDMA/MET500/OPI300/OXY/PCP/THC+ Adulterant Panel, 25tests/kit
CHEMTRON BIOTECH INC
61093D-3C
In Commercial Distribution

  • 00850019007459 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup
Twin Spirit Inc.
61230D
Not in Commercial Distribution

  • 00859144006221 ()
61230D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC/THC/MET/OPI/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
61205D
Not in Commercial Distribution

  • 00859144006078 ()
61205D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC/THC/MET/OPI/AMP/BAR/BZO/MTD/PCP/PPX/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
61210D
Not in Commercial Distribution

  • 00859144006061 ()
61210D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-61026D
Not in Commercial Distribution

  • 00859144006030 ()
C-61026D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-5M-W
Not in Commercial Distribution

  • 00858998006579 ()
PSCupA-5M-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCup-10MMO300
Not in Commercial Distribution

  • 00858998006029 ()
USSCup-10MMO300UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-61012N
In Commercial Distribution

  • 00858984006132 ()
C-61012N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
Lifesign L.L.C.
76025AA2K
In Commercial Distribution

  • 00868348000249 ()
76025AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cassette, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSPA-6MP
Not in Commercial Distribution

  • 00858998006753 ()
PSPA-6MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-6MP
Not in Commercial Distribution

  • 00858998006333 ()
PSDA-6MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD
Instant Tech Subsidiary Acquisition
PSD-12BUP
Not in Commercial Distribution

  • 00858998006289 ()
PSD-12BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, PCP, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60505N-3A
In Commercial Distribution

  • 00858984006088 ()
C-60505N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, MET, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60500N-3A
Not in Commercial Distribution

  • 00858984006071 ()
C-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 00850013035106 ()
  • 10850013035103 ()
  • 20850013035100 ()
ID-CP6-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850013035063 ()
  • 10850013035066 ()
  • 00850013035069 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1254-RCN
In Commercial Distribution

  • 20817038021587 ()
  • 10817038021580 ()
  • 00817038021583 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-4124
In Commercial Distribution

  • 20817038021303 ()
  • 10817038021306 ()
  • 00817038021309 ()
U-CUP-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-6124
In Commercial Distribution

  • 20817038021174 ()
  • 10817038021177 ()
  • 00817038021170 ()
U-CUP-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-3124
In Commercial Distribution

  • 20817038021136 ()
  • 10817038021139 ()
  • 00817038021132 ()
U-CUP-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-20124
In Commercial Distribution

  • 20817038021099 ()
  • 10817038021092 ()
  • 00817038021095 ()
U-CUP-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Mini Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP
UCP BIOSCIENCES, INC.
U-MCUP-10124-POC
In Commercial Distribution

  • 20817038020757 ()
  • 10817038020750 ()
  • 00817038020753 ()
U-MCUP-10124-POC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1134-RCL
In Commercial Distribution

  • 20817038020689 ()
  • 10817038020682 ()
  • 00817038020685 ()
U-CUP-1134-RCL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1134-RCLN
In Commercial Distribution

  • 20817038020672 ()
  • 10817038020675 ()
  • 00817038020678 ()
U-CUP-1134-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-DOA-3124
In Commercial Distribution

  • 20817038020498 ()
  • 10817038020491 ()
  • 00817038020494 ()
U-DOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
"Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 20850721007970 ()
  • 10850721007973 ()
  • 00850721007976 ()
ID-CP6-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007802 ()
  • 10850721007805 ()
  • 00850721007808 ()
  • 30850721007809 ()
ID-CP6-AZ5

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