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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DOA 7 in 1 Test Dipcard W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/OXY/THC/PH-SG-OX
W.H.P.M. INC.
W174 W/AD
In Commercial Distribution

  • 00841824103153 ()
  • 00841824103160 ()
W174 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box, Clia Waived AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC
W.H.P.M. INC.
CW12104
In Commercial Distribution

  • 00841824103054 ()
  • 00841824100824 ()
CW12104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
W.H.P.M. INC.
W6104
In Commercial Distribution

  • 00841824103030 ()
  • 00841824100817 ()
W6104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
W3104
In Commercial Distribution

  • 00841824102972 ()
  • 00841824100763 ()
W3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
W1104
In Commercial Distribution

  • 00841824102941 ()
  • 00841824100732 ()
W1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
W.H.P.M. INC.
CW4104
In Commercial Distribution

  • 00841824102934 ()
  • 00841824100770 ()
CW4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived BARB/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/THC
W.H.P.M. INC.
W8104
In Commercial Distribution

  • 00841824102927 ()
  • 00841824100718 ()
W8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
CW1104
In Commercial Distribution

  • 00841824102910 ()
  • 00841824100732 ()
CW1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
W1104RD
In Commercial Distribution

  • 00841824102286 ()
  • 00841824100732 ()
W1104RD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-14-01
In Commercial Distribution

  • B115ABCARDC14011 ()
  • B115ABCARDC14010 ()
ABCardC-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCupC-14-01
In Commercial Distribution

  • B115ABCUPC14011 ()
  • B115ABCUPC14010 ()
ABCupC-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7070-13
In Commercial Distribution

  • 00817830022832 ()

  • Length: 75 Millimeter
07RD-7070-13

  • 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
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution

  • 00817830022795 ()

  • Length: 75 Millimeter
07RD-7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7113-03
In Commercial Distribution

  • 00817830022719 ()

  • Length: 75 Millimeter
07RD-7113-03

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