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 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
DOA 5 in 1 Test ECO III Cup W/AD, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅢ-354 W/AD
In Commercial Distribution

  • 00841824101999 ()
  • 00841824101418 ()
ECOⅢ-354W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
WCUP3104
In Commercial Distribution

  • 00841824101180 ()
  • 00841824101548 ()
WCUP3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP264 W/AD
In Commercial Distribution

  • 00841824101159 ()
  • 00841824101517 ()
WECCUP264 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO III Cup W/AD, 25Pcs/Box, CLIA Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅢ-254 W/AD
In Commercial Distribution

  • 00841824101067 ()
  • 00841824101425 ()
ECOⅢ-254 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/COC/OPI/PCP/THC/CR-NI-OX-PH-SG
W.H.P.M. INC.
ECOII-154 W/AD9
In Commercial Distribution

  • 00841824101050 ()
  • 00841824100992 ()
ECOII-154 W/AD9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅡ-254 W/AD
In Commercial Distribution

  • 00841824100985 ()
  • 00841824101340 ()
ECOⅡ-254 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/BZO/COC/OPI/THC/CR-NI-PH-OX-SG
W.H.P.M. INC.
ECOII-754 W/AD9
In Commercial Distribution

  • 00841824100923 ()
  • 00841824100015 ()
ECOII-754 W/AD9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Speedy Tests DOA 10 in 1 Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
SPEEDY SOLUTIONS LLC
STDIP3104
In Commercial Distribution

  • 10866415000335 ()
  • 00866415000338 ()
STDIP3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST SplitCup-8+6 w. Adulteration Screen (pH/ S.G./ Oxidant/Nit/Glut/Creatinine) (AMP/BAR/BZO/COC/MAMP/OPI/PCP/THC/)
JANT PHARMACAL CORPORATION
DS208
In Commercial Distribution

  • 10763924208620 ()
  • 00763924208623 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest SplitCup-6 with Adulteration Screen AMP (300), COC (150,) MDMA (500,) M-AMP (500,) OPI (2000,) THC (50.) + (Oxidants, SG, PH.)
JANT PHARMACAL CORPORATION
DS09AC625
In Commercial Distribution

  • 10763924009623 ()
  • 00763924009626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST SplitCup-6+3 w. Adulteration Screen (pH/ S.G./ Oxidant) (AMP1000 /COC 300 /MET 1000/ OPI 2000/ PCP 25/ THC 50)
JANT PHARMACAL CORPORATION
DS08AC625
In Commercial Distribution

  • 10763924008626 ()
  • 00763924008629 ()


  • 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
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
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived, AMP/BZO/COC/OPI/OXY/THC
HEMOSURE INC.
FSCCUP-3864
In Commercial Distribution

  • 00817763022428 ()
  • 00817763022411 ()
FSCCUP-3864

  • 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/MOR/OXY/THC
HEMOSURE INC.
FSCCUP-6664
In Commercial Distribution

  • 00817763021971 ()
  • 00817763021995 ()
FSCCUP-6664

  • 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/mAMP/OPI/THC
HEMOSURE INC.
FSCDIP254
In Commercial Distribution

  • 00817763020561 ()
  • 00817763021230 ()
FSCDIP254

  • 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
u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-20124
In Commercial Distribution

  • 20817038022218 ()
  • 10817038022211 ()
  • 00817038022214 ()
U-DOA-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Drug Test Mini Cups 10-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-MCUP-13104
In Commercial Distribution

  • 20817038022089 ()
  • 10817038022082 ()
  • 00817038022085 ()
U-MCUP-13104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
UCP BIOSCIENCES, INC.
ID-CP10
In Commercial Distribution

  • 20817038021662 ()
  • 10817038021665 ()
  • 00817038021668 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup (COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP) with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MLA-CLIA
In Commercial Distribution

  • 20817038021044 ()
  • 10817038021047 ()
  • 00817038021040 ()
UCC-10-1MLA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MLA-CLIA
In Commercial Distribution

  • 20817038020993 ()
  • 10817038020996 ()
  • 00817038020999 ()
UCC-10-1MLA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MA-CLIA
In Commercial Distribution

  • 20817038020948 ()
  • 10817038020941 ()
  • 00817038020944 ()
UCC-10-1MA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
Quest Diagnostics
UDOA-12CE-0712-01
In Commercial Distribution

  • 00869419000236 ()
  • 30869419000237 ()
DUE-1127-051-19-ONW504A

  • 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
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
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