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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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Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Methamphetamine (mAMP), Marijuana (THC) Opiates (OPI).
GERMAINE LABORATORIES, INC
40425
In Commercial Distribution

  • 00695684404253 ()
  • 00695684404251 ()


  • Cannabinoid/cannabinoid metabolite 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
DrugSmart Cup 14 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/PPX/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
C-61403D
In Commercial Distribution

  • 00850019007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 13 CLIA-Waived Test, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA/BUP, 25tests/kit
CHEMTRON BIOTECH INC
C-61313D
In Commercial Distribution

  • 00850019007626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007411 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 10-Panel Drug Screen Dip Card Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/PCP/ THC, 25pcs/kit
CHEMTRON BIOTECH INC
711J06CT
In Commercial Distribution

  • 00850019007381 ()
711J06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007008 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel DOA Cup, AMP/BAR/BZO/BUP/COC/MET/MTD/MOR300/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
CHEMTRON BIOTECH INC
712K02A
In Commercial Distribution

  • 00850019007923 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO III Cup W/AD, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅢ-354 W/AD
In Commercial Distribution

  • 00841824101999 ()
  • 00841824101418 ()
ECOⅢ-354W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
WCUP3104
In Commercial Distribution

  • 00841824101180 ()
  • 00841824101548 ()
WCUP3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP264 W/AD
In Commercial Distribution

  • 00841824101159 ()
  • 00841824101517 ()
WECCUP264 W/AD

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