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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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A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, and Propoxyphene drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604018
In Commercial Distribution

  • 00690286000018 ()
  • 10690286000015 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601684
In Commercial Distribution

  • 00690286000780 ()
  • 10690286000787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604022
In Commercial Distribution

  • 00690286000049 ()
  • 10690286000046 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC
HEMOSURE INC.
FSCCUP-14124-B300
In Commercial Distribution

  • 00817763021858 ()
  • 00817763021865 ()
FSCCUP-14124-B300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 PNL CLIA WAIVED SQUARE CUP AMP 500, BAR 300, BUP 10, BZO 300, COC 150, MDMA 500, MET 500, MOP 300, MTD 300, OXY 100, THC 50 SVT (CR,NI,OX,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW111701A
In Commercial Distribution

  • 30817405023357 ()
  • 00817405023356 ()
  • 10817405023353 ()
ABTDUAW111701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen Multi 12+3 Drug Cup Test - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 300, OXY 100, PCP 25, THC 50 + pH/NBP/SG
SYNTRON BIORESEARCH, INC.
65C09-5
In Commercial Distribution

  • 20748349000155 ()
  • 10748349000158 ()
  • 00748349000151 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA90X39SUP
In Commercial Distribution

  • 00868680000310 ()
  • 10868680000317 ()
OSA90X39SUP

  • External circulating-air core temperature regulation system pad, single-use
Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA96X39LIT
In Commercial Distribution

  • 10868680000300 ()
  • 00868680000303 ()
  • 20868680000307 ()
OSA96X39LIT

  • External circulating-air core temperature regulation system pad, single-use
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4 Methylenedioxymethamphetamine (MDMA) drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601672
In Commercial Distribution

  • 10690286000299 ()
  • 00690286000292 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen 13+4 (pouch cup): AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, MDMA 500, OPI 300, OXY 100, PCP 25, THC 50 + pH/CRE/SG/GTA
SYNTRON BIORESEARCH, INC.
65D03-17
In Commercial Distribution

  • 20748349000032 ()
  • 10748349000035 ()
  • 00748349000038 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
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