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 ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCECOII-874
In Commercial Distribution

  • 00857338006651 ()
  • 00857338006750 ()
FSCECOII-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007581 ()
  • 30855944007582 ()
ACDOA-6125B-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (10 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007567 ()
  • 30855944007568 ()
ACDOA-6125B-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007281 ()
  • 00855944007284 ()
  • 30855944007285 ()
ACDOA-6125B-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007574 ()
  • 30855944007575 ()
ACDOA-6125B-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007298 ()
  • 00855944007291 ()
  • 30855944007292 ()
ACDOA-6125B-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10CT
Not in Commercial Distribution

  • 00858998006586 ()
PSDA-10CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10X
Not in Commercial Distribution

  • 00858998006494 ()
PSDA-10X

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10BUP
Not in Commercial Distribution

  • 00858998006425 ()
PSDA-10BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOB
Not in Commercial Distribution

  • 00858998006173 ()
USSCupA-7MOB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI2000/AMP/MET/PCP/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-7BP CM
Not in Commercial Distribution

  • 00858998006166 ()
USSCupA-7BP CM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61101Y-3A
In Commercial Distribution

  • 00858984006156 ()
61101Y-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, TCA, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61107N-3A
Not in Commercial Distribution

  • 00858984006064 ()
61107N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61101N-3A
In Commercial Distribution

  • 00858984006057 ()
61101N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived)
NOBLE MEDICAL INC
NBCA-7C-W
In Commercial Distribution

  • 00858886006308 ()
NBCA-7C-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC
W.H.P.M. INC.
W7104
Not in Commercial Distribution

  • 00841824105119 ()
  • 00841824105126 ()
W7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
W20104
In Commercial Distribution

  • 00841824102781 ()
  • 00841824102866 ()
W20104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅡ-264 W/AD
In Commercial Distribution

  • 00841824101111 ()
  • 00841824101470 ()
ECOⅡ-264 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP/BARB/BZO/COC/mAMP/MOR/MTD/OXY/PPX/THC
W.H.P.M. INC.
W5104
In Commercial Distribution

  • 00841824105072 ()
  • 00841824105089 ()
W5104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/TCA/THC
W.H.P.M. INC.
W22104
In Commercial Distribution

  • 00841824103962 ()
  • 00841824103979 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test ECO Cup, 25Pcs/Box, CLIA Waived AMP/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/THC
W.H.P.M. INC.
WECCUP39104
In Commercial Distribution

  • 00841824103948 ()
  • 00841824103955 ()


  • 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/CR-NI-GL
W.H.P.M. INC.
ECOII-254 W/AD6
In Commercial Distribution

  • 00841824103788 ()
  • 00841824103795 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/AD, 25Pcs/Box Clia Waived AMP/BARB/COC/OPI/THC/PH-SG-OX/CR-NI-GL
W.H.P.M. INC.
ECOII-3354 W/AD6
In Commercial Distribution

  • 00841824103207 ()
  • 00841824103214 ()
ECOII-3354 W/AD6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO III Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/OPI/THC/SG-PH-CR
W.H.P.M. INC.
ECOIII-264 W/AD2
In Commercial Distribution

  • 00841824103061 ()
  • 00841824103047 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup W/AD, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/MOR/THC/SG-PH-CR
W.H.P.M. INC.
ECOⅡ-3064 W/AD2
In Commercial Distribution

  • 00841824101753 ()
  • 00182532000571 ()
ECOⅡ-3064 W/AD2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test ECO Cup, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
WECCUP3104
In Commercial Distribution

  • 00841824101234 ()
  • 00841824101593 ()
WECCUP3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/THC + A-strip (Cr/Ox/pH)
CHEMTRON BIOTECH INC
712L17A-CT
In Commercial Distribution

  • 00812203030520 ()


  • 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"
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ10
In Commercial Distribution

  • 20850721007963 ()
  • 10850721007966 ()
  • 00850721007969 ()
ID-CP10-AZ10

  • 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
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007796 ()
  • 10850721007799 ()
  • 00850721007792 ()
  • 30850721007793 ()
ID-CP10-AZ5

  • 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
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007758 ()
  • 10850721007751 ()
  • 00850721007754 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ10
In Commercial Distribution

  • 20850721007680 ()
  • 10850721007683 ()
  • 00850721007686 ()
ID-CP10-DIP-AZ10

  • 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
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ10
In Commercial Distribution

  • 00850013035090 ()
  • 10850013035097 ()
  • 20850013035094 ()
ID-CP10-AZ10

  • 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
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850013035070 ()
  • 10850013035073 ()
  • 00850013035076 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Multi-Drug Screen Test Card with the Integrated iCup® (CR/OX/pH)+ <AMP>+<COC>+<mAMP>+<OPI>+<PCP>+<OXY>+<THC>
Instant Technologies, Inc.
I-DUE-177-491
In Commercial Distribution

  • 10833143000050 ()
  • 00833143000053 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-10X
Not in Commercial Distribution



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

  • 00817405020898 ()


  • 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,MOP,MTD,OXY,PCP,PPX,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-1145A3
In Commercial Distribution

  • 10816862026358 ()
  • 00816862026351 ()
  • 00816862026344 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 12-Panel T-Cup Compact; 50 per case; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
DCDOA-3124-50BX-A
In Commercial Distribution

  • 10816862024897 ()
  • 00816862024890 ()
  • 00816862024883 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen 14-Panel T-Cup: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC,25 per Box
WONDFO USA CO., LTD.
DTDOA-1144-25BX-A
In Commercial Distribution

  • 10816862024552 ()
  • 00816862024555 ()
  • 00816862024562 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Panel Urine Test (10 Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC), 25T/Box
WONDFO USA CO., LTD.
DWDOA-3104-25BX-A
In Commercial Distribution

  • 10816862024026 ()
  • 00816862024029 ()
  • 00816862024036 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • 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 /OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-11
In Commercial Distribution

  • M90107RD7208110 ()

  • Length: 74 Millimeter
07RD7208-11

  • 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 / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-10
In Commercial Distribution

  • M90107RD7208100 ()

  • Length: 74 Millimeter
07RD7208-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-20
In Commercial Distribution

  • M90107RD7071201 ()
  • M90107RD7071200 ()

  • Length: 75 Millimeter
07RD7071-20

  • 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 / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-12
In Commercial Distribution

  • M90107RD7071121 ()
  • M90107RD7071120 ()

  • Length: 75 Millimeter
07RD7071-12

  • 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 / OXY / THC
RAPID DIAGNOSTICS INC
07RD7071-12
In Commercial Distribution

  • 00817830022177 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-05
In Commercial Distribution

  • 00817830022160 ()

  • Length: 75 Millimeter
07RD7071-05

  • 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-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04A
In Commercial Distribution

  • 00817830022153 ()

  • Length: 75 Millimeter
07RD7071-04A

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