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 Class Implantable

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12 PNL CLIA WAIVED SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 with SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW112701A
In Commercial Distribution

  • 10817405023247 ()
  • 00817405023240 ()
  • 30817405023241 ()
ABTDUAW112701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi-Drug One Step Cup - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 TCA1000
BTNX Inc
D12.21-1V
In Commercial Distribution

  • 00722066004722 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167611 ()
  • 16936983167618 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FDA Clia Waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50/BUP10
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983165723 ()
  • 16936983165720 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12CLIA
Not in Commercial Distribution

USSCUPA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-1144A3
In Commercial Distribution

  • 10816862026532 ()
  • 00816862026535 ()
  • 00816862026528 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
CDOA-1144
In Commercial Distribution

  • 10816862026518 ()
  • 00816862026511 ()
  • 00816862026504 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP1000,BAR,BUP,BZO,COC300,EDDP,mAMP1000,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-2145
In Commercial Distribution

  • 10816862024200 ()
  • 00816862024203 ()
  • 00816862024210 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Drug Urine Test Cup, 14-Panel U-Cup, 5 per Box; AMP,BAR,BUP,BZO,COC,MET,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
DUDOA-1144-5BX-A
In Commercial Distribution

  • 10816862024163 ()
  • 00816862024166 ()
  • 00816862024173 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup 5 per Box; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
DTDOA-1144-5BX-A
In Commercial Distribution

  • 10816862023944 ()
  • 00816862023947 ()
  • 00816862023954 ()


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