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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12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6125A3
In Commercial Distribution

  • 10816862020264 ()
  • 00816862020267 ()
  • 00816862029260 ()
TDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6124A3
In Commercial Distribution

  • 10816862020240 ()
  • 00816862020243 ()
  • 00816862029246 ()
TDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)
Cliawaived, Inc.
CLIA-RDTC-12-02
In Commercial Distribution

  • 00816610020662 ()
CLIA-RDTC-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7110-22
In Commercial Distribution

  • M90107RD7110220 ()

  • Length: 74 Millimeter
07RD7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0
In Commercial Distribution

  • 00816036027160 ()
  • 00816036026668 ()
SCP-31107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0-A
In Commercial Distribution

  • 00816036027092 ()
  • 00816036026590 ()
SCP-6157-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-9104-0
In Commercial Distribution

  • 00816036025890 ()
  • 00816036026378 ()
SDP-9104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BUP/BZO/COC/MAMP/MDMA/MOR/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-8104-0
In Commercial Distribution

  • 00816036025883 ()
  • 00816036026361 ()
SDP-8104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-6104-0
In Commercial Distribution

  • 00816036025876 ()
  • 00816036026354 ()
SDP-6104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/OPI/MDMA/MTD/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-4104-0
In Commercial Distribution

  • 00816036025845 ()
  • 00816036026323 ()
SDP-4104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MTD/OPI/PCP/TCA/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1104-0
In Commercial Distribution

  • 00816036025838 ()
  • 00816036026316 ()
SDP-1104-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0-A
In Commercial Distribution

  • 00816036025043 ()
  • 00816036025210 ()
STATⅡ-2167-3-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0
In Commercial Distribution

  • 00816036026552 ()
  • 00816036027054 ()
SCP-21107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0-A
In Commercial Distribution

  • 00816036026538 ()
  • 00816036027030 ()
SCP-3257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, 25Pcs/Box AMP/COC/mAMP/OPI/THC + CR,OX,pH
MICRO DISTRIBUTING, L.C
SCP-1257-0-A
In Commercial Distribution

  • 00816036026514 ()
  • 00816036027016 ()
SCP-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard w/AD, COC/MAMP/OPI/PCP/THC + pH,CR,OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-354-0-A
In Commercial Distribution

  • 00816036025715 ()
  • 00816036026194 ()
SDP-354-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-6167-0-A
In Commercial Distribution

  • 00816036025050 ()
  • 00816036025227 ()
STATⅡ-6167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Dipcard, 25Pcs/Box BUP/BZO/COC/MOR/MTD/THC
MICRO DISTRIBUTING, L.C
SDP-464
In Commercial Distribution

  • 00816036021786 ()
  • 00816036021793 ()
SDP-464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Cup,25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-2167
In Commercial Distribution

  • 00816036021298 ()
  • 00816036021472 ()
SCP-2167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-1257
In Commercial Distribution

  • 00816036020802 ()
  • 00816036021014 ()
STATⅡ-1257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-6257
In Commercial Distribution

  • 00816036020796 ()
  • 00816036021007 ()
STATⅡ-6257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-164
In Commercial Distribution

  • 00816036020260 ()
  • 00816036020642 ()
SDP-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7125A3
In Commercial Distribution

  • 10816862020325 ()
  • 00816862020328 ()
  • 00816862029321 ()
TDOA-7125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/THC
HEMOSURE INC.
FSCDIP11024
In Commercial Distribution

  • 00817763020431 ()
  • 00817763021100 ()
FSCDIP11024

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived COC/THC
HEMOSURE INC.
FSCDIP124
In Commercial Distribution

  • 00817763020417 ()
  • 00817763021087 ()
FSCDIP124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC / OPI / M-AMP
RAPID DIAGNOSTICS INC
07RD7063-14
In Commercial Distribution

  • 00817830021217 ()

  • Length: 75 Millimeter
07RD7063-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7063-13A
In Commercial Distribution

  • 00817830021200 ()

  • Length: 75 Millimeter
07RD7063-13A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-13
In Commercial Distribution

  • 00817830021194 ()

  • Length: 75 Millimeter
07RD7063-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7063-07A
In Commercial Distribution

  • 00817830021149 ()

  • Length: 75 Millimeter
07RD7063-07A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-07
In Commercial Distribution

  • 00817830021132 ()

  • Length: 75 Millimeter
07RD7063-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7063-04A
In Commercial Distribution

  • 00817830021088 ()

  • Length: 75 Millimeter
07RD7063-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-04
In Commercial Distribution

  • 00817830021071 ()

  • Length: 75 Millimeter
07RD7063-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7063-02A
In Commercial Distribution

  • 00817830021040 ()

  • Length: 75 Millimeter
07RD7063-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-02
In Commercial Distribution

  • 00817830021033 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7063-01A
In Commercial Distribution

  • 00817830021026 ()

  • Length: 75 Millimeter
07RD7063-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-01
In Commercial Distribution

  • 00817830021019 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7110-19
In Commercial Distribution

  • 00817830020302 ()

  • Height: 74 Millimeter
07RD7110-19

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