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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 / BAR / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-13
In Commercial Distribution

  • M90107RD7070131 ()
  • M90107RD7070130 ()

  • Length: 75 Millimeter
07RD7070-13

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-12
In Commercial Distribution

  • M90107RD7070121 ()
  • M90107RD7070120 ()

  • Length: 75 Millimeter
07RD7070-12

  • 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 / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-11
In Commercial Distribution

  • M90107RD7070111 ()
  • M90107RD7070110 ()

  • Length: 75 Millimeter
07RD7070-11

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • 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 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
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
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCupC-14-01
In Commercial Distribution

  • B115ABCUPC14011 ()
  • B115ABCUPC14010 ()
ABCupC-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-14-01
In Commercial Distribution

  • B115ABCARDC14011 ()
  • B115ABCARDC14010 ()
ABCardC-14-01

  • 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
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731989 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731972 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731965 ()


  • 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
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