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: COC / M-AMP / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7111-02
In Commercial Distribution

  • M90107RD7111020 ()

  • Length: 74 Millimeter
07RD7111-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7111-01
In Commercial Distribution

  • M90107RD7111010 ()

  • Length: 74 Millimeter
07RD7111-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-40
In Commercial Distribution

  • M90107RD7064401 ()
  • M90107RD7064400 ()

  • Length: 75 Millimeter
07RD7064-40

  • 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/ OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution

  • M90107RD7064051 ()
  • M90107RD7064050 ()
  • M90107RD7064052 ()

  • Length: 75 Millimeter
07RD7064-05

  • 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 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-04
In Commercial Distribution

  • M90107RD7064041 ()
  • M90107RD7064040 ()

  • Length: 75 Millimeter
07RD7064-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI-2000 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-03A
In Commercial Distribution

  • M90107RD706403A0 ()
  • M90107RD706403A1 ()

  • Length: 75 Millimeter
07RD7064-03A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-03
In Commercial Distribution

  • M90107RD7064031 ()
  • M90107RD7064030 ()

  • Length: 75 Millimeter
07RD7064-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-02
In Commercial Distribution

  • M90107RD7064021 ()
  • M90107RD7064020 ()

  • Length: 75 Millimeter
07RD7064-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-01
In Commercial Distribution

  • M90107RD7064011 ()
  • M90107RD7064010 ()

  • Length: 75 Millimeter
07RD7064-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET/MTD/MOR/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712M08-G
In Commercial Distribution

  • 00812203030858 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
PCU-13FCW-25
In Commercial Distribution

  • 00812203030773 ()
PCU-13FCW-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue 7-Panel DOA Dip Card, BZO/COC150/MET500/MOR/OXY/PCP/THC (Ni/pH/Gl)(Cr/SG/Ox)
CHEMTRON BIOTECH INC
711G05A-CT
In Commercial Distribution

  • 00812203030513 ()


  • 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)
CHEMTRON BIOTECH INC
712L16A-G
In Commercial Distribution

  • 00812203030261 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/PPX/THC (Cr/SG/Bl)
CHEMTRON BIOTECH INC
712L15A-G
In Commercial Distribution

  • 00812203030216 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(COC/THC)+(MET/OPI)+(PCP/AMP)+BAR+BZO+MTD+OXY with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10MO
Not in Commercial Distribution

  • 00816565021516 ()
IMCA-10MO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immutest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMDA-9AMJ
Not in Commercial Distribution

  • 00816565021318 ()
IMDA-9AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445116
In Commercial Distribution

  • 00842768015441 ()
  • 00630414004891 ()
K5095

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/PCP/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D11.3-1P29-25
In Commercial Distribution

  • 00722066003664 ()
  • 00722066004050 ()
D11.3-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.6-1P29-25
In Commercial Distribution

  • 00722066003312 ()
  • 00722066004043 ()
D10.6-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.6-1G29-25
In Commercial Distribution

  • 00722066003107 ()
  • 00722066004142 ()
D10.6-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MDMA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Phencyclidine, Barbiturates, Benzodiazepines, Methadone, 3,4-Methylenedioxy-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.3-1G29-25
In Commercial Distribution

  • 00722066000915 ()
  • 00722066004135 ()
D10.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1G29-25
In Commercial Distribution

  • 00722066000908 ()
  • 00722066004128 ()
D10.1-1G29

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Clinical Guard
THC Marijuana Drug Test Strip
In Commercial Distribution

  • 00851950008123 ()
  • 00851950008062 ()
  • 10851950008120 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC-COOH 1000 NG/ML
UTAK LABORATORIES, INC.
THC 1000 U F SDHL
In Commercial Distribution

  • B800THC1000UFSDHL5 ()
  • B800THC1000UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 1000 U F SDHL

  • Multiple drugs of abuse IVD, control
THC-COOH 25 NG/ML
UTAK LABORATORIES, INC.
THC 25 U F SDHL
In Commercial Distribution

  • B800THC25UFSDHL5 ()
  • B800THC25UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 25 U F SDHL

  • Multiple drugs of abuse IVD, control
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCECOII-654
In Commercial Distribution

  • 00857338006613 ()
  • 00857338006705 ()
FSCECOII-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCECOII-354
In Commercial Distribution

  • 00857338006606 ()
  • 00857338006699 ()
FSCECOII-354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCECOII-254
In Commercial Distribution

  • 00857338006590 ()
  • 00857338006682 ()
FSCECOII-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/COC/OPI/PCP/THC
HEMOSURE INC.
FSCECOII-154
In Commercial Distribution

  • 00857338006583 ()
  • 00857338006675 ()
FSCECOII-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/MOR/PCP/THC
HEMOSURE INC.
FSCW3464
In Commercial Distribution

  • 00857338006385 ()
  • 00841824101852 ()
FSCW3464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1  Test Dip card, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCW564
In Commercial Distribution

  • 00857338006378 ()
  • 00841824100503 ()
FSCW564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1  Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCW264
In Commercial Distribution

  • 00857338006361 ()
  • 00841824101845 ()
FSCW264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit, 12 test items Cup; AMP/COC/OXY/THC/PCP/MDMA/MOP/BZO/BAR/MET/MTD/TCA
IDUN SOLUTIONS LLC
IDOA-7225RC-5P
Not in Commercial Distribution

  • 00857275007063 ()
  • 00857275007162 ()


  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-61203D
Not in Commercial Distribution

  • 00859144006054 ()
C-61203D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-8P
Not in Commercial Distribution

  • 00858998006401 ()
PSDA-8P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+COC+THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-8MO
Not in Commercial Distribution

  • 00858998006395 ()
PSDA-8MO

  • 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 Tech Subsidiary Acquisition
PSDA-8MBO300
Not in Commercial Distribution

  • 00858998006388 ()
PSDA-8MBO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-8MBO
Not in Commercial Distribution

  • 00858998006371 ()
PSDA-8MBO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZ0/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MDMA with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-8M
Not in Commercial Distribution

  • 00858998006364 ()
PSDA-8M

  • 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 Tech Subsidiary Acquisition
USSCupA-5M
Not in Commercial Distribution

  • 00858998006142 ()
USSCupA-5M

  • 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 Tech Subsidiary Acquisition
USSCup-10M
Not in Commercial Distribution

  • 00858998006012 ()
USSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-61203N
In Commercial Distribution

  • 00858984006149 ()
C-61203N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MDMA/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-7MD-W
Not in Commercial Distribution

  • 00858998006616 ()
PSCupA-7MD-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
CSC-8104
In Commercial Distribution

  • 00850557007942 ()
  • 00850557007959 ()
  • 10850557007956 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-4104
In Commercial Distribution

  • 00850557007928 ()
  • 00850557007935 ()
  • 10850557007932 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
CSC-3104
In Commercial Distribution

  • 00850557007904 ()
  • 00850557007911 ()
  • 10850557007918 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
PSC-DOA-8104
In Commercial Distribution

  • 00850557007669 ()
  • 00850557007676 ()
  • 10850557007673 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7104
In Commercial Distribution

  • 00850557007621 ()
  • 00850557007638 ()
  • 10850557007635 ()


  • 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
MERGERS MARKETING, INC.
PSC-DOA-4104
In Commercial Distribution

  • 00850557007584 ()
  • 00850557007591 ()
  • 10850557007598 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-3104
In Commercial Distribution

  • 00850557007508 ()
  • 00850557007515 ()
  • 10850557007512 ()


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