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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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Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-12M-W
Not in Commercial Distribution

  • 00858998006685 ()
PSCupA-12M-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
Instant Technologies, Inc.
I-DXP-167-02
In Commercial Distribution

  • 00858945006812 ()
I-DXP-167-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup for (BZO/BAR)+(COC/THC)+(MET/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl. S.G.
NOBLE MEDICAL INC
ITCA-12M-W
In Commercial Distribution

  • 00858886006292 ()
ITCA-12M-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Opiates (OPI), Benzodiazpines (BZO).
GERMAINE LABORATORIES, INC
46325
In Commercial Distribution

  • 00695684463250 ()
  • 00695684463251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific 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
A rapid screening test system for the detection of Amphetamine, Benzodiazepines, Cocaine, Opiates, and THC (Cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600680
Not in Commercial Distribution

  • 00690286000377 ()
  • 10690286000374 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, and Cocaine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601643
Not in Commercial Distribution

  • 10690286000244 ()
  • 00690286000247 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, and Cocaine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601593
Not in Commercial Distribution

  • 10690286000145 ()
  • 00690286000148 ()


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

  • 00850557007706 ()
  • 00850557007713 ()
  • 10850557007710 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-8105
In Commercial Distribution

  • 00850798007688 ()
  • 00850798007671 ()
  • 00850798007664 ()


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

  • 10851000007110 ()
  • 00851000007113 ()
  • 00851000007106 ()


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