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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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ABTDOAO16701A, 1T/kit, AMP500/COC150/FYL1/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177238 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, MET, OPI with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60500N-3A
Not in Commercial Distribution

  • 00858984006071 ()
C-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel One Step DOA Cup (5.1) - COC300 AMP1000 MET1000 THC50 OPI2000
BTNX Inc
D5.1-1VF
In Commercial Distribution

  • 00722066007563 ()
  • 10722066007560 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-564
In Commercial Distribution

  • 00895330002967 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 6 Panel Dip Card, CLIA AMP1000/BZO300/COC300/mAMP1000/MOP2000
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002813 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
5 Panel Clia Cup COC/THC/OPI/AMP/mAMP
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-254
In Commercial Distribution

  • 00895330002806 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
Healgen (DrugConfirm) - 5 Panel Dip Card - AMP1000/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-254
In Commercial Distribution

  • 00895330002707 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 5 Panel Dip Card - CLIA Waived - BZO300/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-654
In Commercial Distribution

  • 00895330002646 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Prime Screen® Multi-Panel Urine Test (5-Panel Card: AMP, COC, mAMP, OPI, THC), 5T/Bo
WONDFO USA CO., LTD.
DWDOA-254-5BX-A
In Commercial Distribution

  • 10816862023982 ()
  • 00816862023985 ()
  • 00816862023992 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
DWDOA-754-5BX-A
In Commercial Distribution

  • 10816862023678 ()
  • 00816862023671 ()
  • 00816862023688 ()
DWDOA-754-5BX-A

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