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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T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BUP, BZO, COC, MDMA, MET500, MOP, MTD, OXY, PCP, TCA, THC>
Instant Technologies, Inc.
ACDOA-10135
In Commercial Distribution

  • 00817405021024 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSCupA-10OM
Not in Commercial Distribution

  • 00817405020676 ()
PSCupA-10OM

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

  • 00816036027177 ()
  • 00816036026675 ()
SCP-21107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 8 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2387-0-A
In Commercial Distribution

  • 00816036027153 ()
  • 00816036026651 ()
SCP-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-71127-0
In Commercial Distribution

  • 00816036025128 ()
  • 00816036025289 ()
STATⅡ-71127-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
MICRO DISTRIBUTING, L.C
STATⅡ-6167
In Commercial Distribution

  • 00816036021830 ()
  • 00816036021847 ()
STATⅡ-6167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2387-A
In Commercial Distribution

  • 00816036021342 ()
  • 00816036021526 ()
SCP-2387-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 10 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATⅡ-21107
In Commercial Distribution

  • 00816036020918 ()
  • 00816036021120 ()
STATⅡ-21107

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

  • 00816036020819 ()
  • 00816036021021 ()
STATⅡ-1257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 9 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-194
In Commercial Distribution

  • 00816036020338 ()
  • 00816036020727 ()
SDP-194

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-2135A3
In Commercial Distribution

  • 10816862026396 ()
  • 00816862026399 ()
  • 00816862026382 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 12-Panel Card; 25 per box; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DWDOA-6125-25BX-A
In Commercial Distribution

  • 10816862026051 ()
  • 00816862026054 ()
  • 00816862026047 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact without THC; AMP500,BAR,BUP,BZO,COC150,MDMA,MET500,MOP,MTD,OXY,PCP,PPX,TCA with 3AD
WONDFO USA CO., LTD.
CDOA-L9135NTA3
In Commercial Distribution

  • 10816862023296 ()
  • 00816862023299 ()
  • 00816862023305 ()
CDOA-L9135NTA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BZO/COC/OPI/THC
HEMOSURE INC.
FSCDIP754
In Commercial Distribution

  • 00817763021643 ()
  • 00817763021667 ()
FSCDIP754

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCDIP5964
In Commercial Distribution

  • 00817763020653 ()
  • 00817763021346 ()
FSCDIP5964

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/mAMP/MOR/PCP/THC
HEMOSURE INC.
FSCCUP-3464
In Commercial Distribution

  • 00817763020639 ()
  • 00817763021308 ()
FSCCUP-3464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1  Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCCUP-264
In Commercial Distribution

  • 00817763020615 ()
  • 00817763021285 ()
FSCCUP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCDIP654
In Commercial Distribution

  • 00817763020585 ()
  • 00817763021254 ()
FSCDIP654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCDIP354
In Commercial Distribution

  • 00817763020578 ()
  • 00817763021247 ()
FSCDIP354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/OPI/PCP/THC
HEMOSURE INC.
FSCDIP154
In Commercial Distribution

  • 00817763020554 ()
  • 00817763021223 ()
FSCDIP154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-17
In Commercial Distribution

  • M90107RD7207170 ()

  • Length: 74 Millimeter
07RD7207-17

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-16
In Commercial Distribution

  • M90107RD7207160 ()

  • Length: 74 Millimeter
07RD7207-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-14
In Commercial Distribution

  • M90107RD7207140 ()

  • Length: 74 Millimeter
07RD7207-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-10
In Commercial Distribution

  • M90107RD7207100 ()

  • Length: 74 Millimeter
07RD7207-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-02
In Commercial Distribution

  • M90107RD7207020 ()

  • Length: 74 Millimeter
07RD7207-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7184-02A
In Commercial Distribution

  • M90107RD718402A1 ()
  • M90107RD718402A0 ()

  • Length: 75 Millimeter
07RD7184-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-06
In Commercial Distribution

  • M90107RD7113060 ()

  • Length: 74 Millimeter
07RD7113-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-05
In Commercial Distribution

  • M90107RD7113050 ()

  • Length: 74 Millimeter
07RD7113-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / THC / CRE
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-04
In Commercial Distribution

  • M90107RD7113040 ()

  • Length: 74 Millimeter
07RD7113-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-03
In Commercial Distribution

  • M90107RD7113030 ()

  • Length: 74 Millimeter
07RD7113-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7113-02
In Commercial Distribution

  • M90107RD7113020 ()

  • Length: 74 Millimeter
07RD7113-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP/ MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-19
In Commercial Distribution

  • M90107RD7070191 ()
  • M90107RD7070190 ()

  • Length: 75 Millimeter
07RD7070-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-17
In Commercial Distribution

  • M90107RD7070171 ()
  • M90107RD7070170 ()

  • Length: 75 Millimeter
07RD7070-17

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-15
In Commercial Distribution

  • M90107RD7070151 ()
  • M90107RD7070150 ()

  • Length: 75 Millimeter
07RD7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-14
In Commercial Distribution

  • M90107RD7070141 ()
  • M90107RD7070140 ()

  • Length: 75 Millimeter
07RD7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-13
In Commercial Distribution

  • M90107RD7070131 ()
  • M90107RD7070130 ()

  • Length: 75 Millimeter
07RD7070-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-12
In Commercial Distribution

  • M90107RD7070121 ()
  • M90107RD7070120 ()

  • Length: 75 Millimeter
07RD7070-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-11
In Commercial Distribution

  • M90107RD7070111 ()
  • M90107RD7070110 ()

  • Length: 75 Millimeter
07RD7070-11

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