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 / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution

  • 00817830022795 ()

  • Length: 75 Millimeter
07RD-7070-14

  • 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 / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-05A
In Commercial Distribution

  • 00817830022047 ()

  • Length: 75 Millimeter
07RD7070-05A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-04
In Commercial Distribution

  • 00817830022016 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-03
In Commercial Distribution

  • 00817830021996 ()

  • Length: 75 Millimeter
07RD7070-03

  • 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 / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-01
In Commercial Distribution

  • 00817830021958 ()

  • Length: 75 Millimeter
07RD7070-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC,CR,PH,SG
Eterbio, Inc.
ETG011025
In Commercial Distribution

  • 06977469280189 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP;BAR;BUP;BZO;COC;MDMA;MET;MOP;MTD;OXY;PCP;THC;CR;PH;SG
Eterbio, Inc.
ETG004025
In Commercial Distribution

  • 06977469280042 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300, MAD 300, THC 50
SYNTRON BIORESEARCH, INC.
60719
In Commercial Distribution

  • 20748349000131 ()
  • 10748349000134 ()
  • 00748349000137 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN MULTI 6+1 DRUG CUP TEST - AMP 1000, BZD 300, COC 300, MET 1000, OPI 300, THC 50 + ALC
SYNTRON BIORESEARCH, INC.
65646-19
In Commercial Distribution

  • 20748349000292 ()
  • 10748349000295 ()
  • 00748349000298 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
Quest Diagnostics
UDOA-12CE-0712-01
In Commercial Distribution

  • 00869419000236 ()
  • 30869419000237 ()
DUE-1127-051-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (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, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1G29-25
In Commercial Distribution

  • 00722066003701 ()
  • 00722066004159 ()
D12.1-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.5-1T
In Commercial Distribution

  • 00722066003695 ()
  • 00722066004098 ()
D12.5-1T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-6125
In Commercial Distribution

  • 00850557007966 ()
  • 00850557007973 ()
  • 10850557007970 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-6125
In Commercial Distribution

  • 00850557007683 ()
  • 00850557007690 ()
  • 10850557007697 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:AMP | BAR | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-7125
In Commercial Distribution

  • 00850557007249 ()
  • 00850557007256 ()
  • 10850557007253 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Eleven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR| BZO| COC | MDMA | MET | OPI | MTD | PPX | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-1114
In Commercial Distribution

  • 00850557007065 ()
  • 00850557007072 ()
  • 10850557007079 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC With Alcohol
MERGERS MARKETING, INC.
PSC-DOA-4104A
In Commercial Distribution

  • 10851000007073 ()
  • 00851000007076 ()
  • 00851000007069 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MOP | MTD | OXY | PCP| TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7125
In Commercial Distribution

  • 00851000007120 ()
  • 10851000007127 ()
  • 20851000007124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH)
Medical Disposables Corp
MDC-6125-A3
In Commercial Distribution

  • 00851721007867 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH)
Medical Disposables Corp
MDC-6125-A3
In Commercial Distribution

  • 00851721007836 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(OXI-SG-PH)
Medical Disposables Corp
MDC-6125-A3
In Commercial Distribution

  • 00851721007812 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCECOII-4854
In Commercial Distribution

  • 00857338006897 ()
  • 00857338006903 ()
FSCECOII-4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/THC
HEMOSURE INC.
FSCECOII-2974
In Commercial Distribution

  • 00857338006798 ()
  • 00857338006804 ()
FSCECOII-2974

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCECOII-174
In Commercial Distribution

  • 00857338006668 ()
  • 00857338006743 ()
FSCECOII-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCECOII-874
In Commercial Distribution

  • 00857338006651 ()
  • 00857338006750 ()
FSCECOII-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007581 ()
  • 30855944007582 ()
ACDOA-6125B-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007574 ()
  • 30855944007575 ()
ACDOA-6125B-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (10 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007567 ()
  • 30855944007568 ()
ACDOA-6125B-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007298 ()
  • 00855944007291 ()
  • 30855944007292 ()
ACDOA-6125B-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007281 ()
  • 00855944007284 ()
  • 30855944007285 ()
ACDOA-6125B-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC) and Cocaine and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601587
Not in Commercial Distribution

  • 00690286000131 ()
  • 10690286000138 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER MMDOAY6125
In Commercial Distribution

  • 10850011007720 ()
  • 00850011007723 ()
  • 00850011007570 ()
MER MMDOAY6125

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • 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
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER HCDOAY6125
In Commercial Distribution

  • 00850011007334 ()
  • 00850011007327 ()
  • 00850011007310 ()
MER HCDOAY6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, AMP/BAR/BZO/COC150/MDMA/MET500/MTD/MOR300/OXY/PCP/PPX/THC/A-Strip (Cr/SG/Bl), 25tests/kit
CHEMTRON BIOTECH INC
KCUR920093
In Commercial Distribution

  • 00850019007862 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 9-Panel Drug Screen Dip Card Tests with A-Strip, AMP/BAR/BZO/COC/MET/MTD/MOR300/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711I02ACT
In Commercial Distribution

  • 00850019007374 ()
711I02ACT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Dip Card Tests COC/MOR300/MET/THC/AMP/PCP/BZO/BAR/ MTD/OXY/MDMA/BUP, 25pcs/kit
CHEMTRON BIOTECH INC
711L02OS
In Commercial Distribution

  • 00850019007022 ()
711L02OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01CT
In Commercial Distribution

  • 00850019007015 ()
712L01CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10CT
Not in Commercial Distribution

  • 00858998006586 ()
PSDA-10CT

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