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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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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
Kit, OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector), Drape and Foot Switch Cover. Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31046
In Commercial Distribution

  • 10618125190789 ()
  • 00618125190775 ()
8849777

  • Medical equipment/instrument drape, single-use
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
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
BIOMERIEUX , INC.
900-00003
In Commercial Distribution

  • 00860007326912 ()


  • Package sealing unit
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

  • 00860001731965 ()


  • 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
"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


  • Electromyograph
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
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