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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-15
In Commercial Distribution

  • M90107RD7112150 ()

  • Length: 74 Millimeter
07RD7112-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-13
In Commercial Distribution

  • M90107RD7112130 ()
  • M90107RD7112131 ()

  • Length: 74 Millimeter
07RD7112-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-12
In Commercial Distribution

  • M90107RD7112120 ()

  • Length: 74 Millimeter
07RD7112-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-02
In Commercial Distribution

  • M90107RD7112020 ()

  • Length: 74 Millimeter
07RD7112-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCup-10M
In Commercial Distribution

USSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCupA-5M
In Commercial Distribution

USSCupA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BZO, COC, MDMA, MET, MOP, MTD, OXY, PCP, TCA, THC>
Instant Technologies, Inc.
ACDOA-7125
In Commercial Distribution

  • 00817405021017 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-8MBO300
Not in Commercial Distribution

  • 00817405020836 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 14 Panel THC/COC/PCP/mAMP/AMP/MDMA/TCA/BAR/BZO/MTD/OXY/PPX/BUP/OPI
RITE AID CORPORATION
8024512
In Commercial Distribution

  • 00011822001670 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Propoxyphene IVD, reagent
  • Nortriptyline IVD, reagent
mLife Verify 11 Panel Oral Fluid Drug Test FYL AMP COC MET OPI THC BAR BZO MDMA OXY PCP
Mlife Diagnostics, LLC
MV002.11.0001EI
In Commercial Distribution

  • G474MV002110001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP500/BUP/BZO/COC150/MTD/OPI/OXY/THC
W.H.P.M. INC.
W3884
In Commercial Distribution

  • 00841824104761 ()
  • 10841824104768 ()
W3884

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
UCP BIOSCIENCES, INC.
UDO-6123
In Commercial Distribution

  • 20817038021907 ()
  • 10817038021900 ()
  • 00817038021903 ()
UDO-6123

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Cup Drug Test Screen 10 Panel Drug Test Cup (BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC)
UCP BIOSCIENCES, INC.
U-CUP-7104
In Commercial Distribution

  • 20817038021860 ()
  • 10817038021863 ()
  • 00817038021866 ()
U-CUP-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML
In Commercial Distribution

  • 20817038021754 ()
  • 10817038021757 ()
  • 00817038021750 ()
UCC-12-1ML

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1M
In Commercial Distribution

  • 20817038021747 ()
  • 10817038021740 ()
  • 00817038021743 ()
UCC-12-1M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-8134-RCN
In Commercial Distribution

  • 20817038020641 ()
  • 10817038020644 ()
  • 00817038020647 ()
U-CUP-8134-RCN

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

  • 20850721007420 ()
  • 10850721007423 ()
  • 00850721007426 ()
ID-CP6-AZ5

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

  • 20850721007413 ()
  • 10850721007416 ()
  • 00850721007419 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61060D-6AB
In Commercial Distribution

  • 00812203030780 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/COC/THC/OPI2000/MET/PCP/BAR/BZO/MTD/OXY + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61020D-6AB
In Commercial Distribution

  • 00812203030612 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-ALT
In Commercial Distribution

  • 00812203030490 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-LC
In Commercial Distribution

  • 00812203030353 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit
CHEMTRON BIOTECH INC
712M06
In Commercial Distribution

  • 00812203030056 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712G03A
In Commercial Distribution

  • 00812203030025 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 7 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2277-0-A
In Commercial Distribution

  • 00816036027122 ()
  • 00816036026620 ()
SCP-2277-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-2124-0
In Commercial Distribution

  • 00816036025944 ()
  • 00816036026422 ()
SDP-2124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BUP/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-6124-0
In Commercial Distribution

  • 00816036025937 ()
  • 00816036026415 ()
SDP-6124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/PPX/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1124-0
In Commercial Distribution

  • 00816036025920 ()
  • 00816036026408 ()
SDP-1124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127-0
In Commercial Distribution

  • 00816036025166 ()
  • 00816036025326 ()
FST-71127-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 8 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2387-0-A
In Commercial Distribution

  • 00816036025074 ()
  • 00816036025234 ()
STATⅡ-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2167-A
In Commercial Distribution

  • 00816036021311 ()
  • 00816036021496 ()
SCP-2167-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-1257-A
In Commercial Distribution

  • 00816036021281 ()
  • 00816036021465 ()
SCP-1257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box THC/COC/OPI/mAMP/PCP/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-3257-A
In Commercial Distribution

  • 00816036021267 ()
  • 00816036021441 ()
SCP-3257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-6157-A
In Commercial Distribution

  • 00816036021243 ()
  • 00816036021427 ()
SCP-6157-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-184
In Commercial Distribution

  • 00816036020321 ()
  • 00816036020710 ()
SDP-184

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST - 6 Drug Cup (urine strip cup) AMP (1000), COC (300), OPI (2000), MET (1000), THC (50), PCP (25)
JANT PHARMACAL CORPORATION
DS87S625
In Commercial Distribution

  • 10763924087539 ()
  • 00763924087532 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Azure Biotech, Inc.
AZC-8105
In Commercial Distribution

  • 00810022630402 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
Quest Diagnostics
UDOA-6CA-0503-01
In Commercial Distribution

  • 00869419000205 ()
  • 20869419000209 ()
DUA-167-012-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Benzodiazepines, Barbiturate, Cocaine and THC metabolites in urine.
BTNX Inc
D12.8-1P29-25
In Commercial Distribution

  • 00722066003671 ()
  • 00722066004081 ()
D12.8-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturate, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1P29-25
In Commercial Distribution

  • 00722066003541 ()
  • 00722066004067 ()
D12.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.
BTNX Inc
D12.8.1-1P29-25
In Commercial Distribution

  • 00722066005361 ()
  • 10722066005368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel DOA Cup, AMP/BAR/BZO/BUP/COC/MET/MTD/MOR300/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
CHEMTRON BIOTECH INC
712K02A
In Commercial Distribution

  • 00850019007923 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 14 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/PPX/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
C-61403D
In Commercial Distribution

  • 00850019007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 13 CLIA-Waived Test, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA/BUP, 25tests/kit
CHEMTRON BIOTECH INC
C-61313D
In Commercial Distribution

  • 00850019007626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007411 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 10-Panel Drug Screen Dip Card Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/PCP/ THC, 25pcs/kit
CHEMTRON BIOTECH INC
711J06CT
In Commercial Distribution

  • 00850019007381 ()
711J06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007008 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA2135
In Commercial Distribution

  • 00850011007105 ()
  • 10850011007102 ()
  • 20850011007109 ()
TNR CDOA2135

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Methamphetamine (mAMP), Marijuana (THC) Opiates (OPI).
GERMAINE LABORATORIES, INC
40425
In Commercial Distribution

  • 00695684404253 ()
  • 00695684404251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
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