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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PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX drugs of abuse test cup
Twin Spirit Inc.
61093D-3C
Not in Commercial Distribution

  • 00859144006214 ()
61093D-3C

  • 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 Tech Subsidiary Acquisition
PSCupA-10OM
Not in Commercial Distribution

  • 00858998006982 ()
PSCupA-10OM

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

  • 00858998006661 ()
PSCupA-10MO

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

  • 00858998006647 ()
PSCupA-10AM

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

  • 00858998006272 ()
PSCupA-10MA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-6MB
Not in Commercial Distribution

  • 00858998006159 ()
USSCupA-6MB

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

  • 00858998006654 ()
PSCupA-10MBO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-4104
In Commercial Distribution

  • 10850557007277 ()
  • 00850557007270 ()
  • 00850557007263 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-3104
In Commercial Distribution

  • 10850557007239 ()
  • 00850557007232 ()
  • 00850557007225 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MET | MOR | MTD | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-1104-051
In Commercial Distribution

  • 00850557007041 ()
  • 00850557007058 ()
  • 10850557007055 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | PCP | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-1104
In Commercial Distribution

  • 00850557007027 ()
  • 00850557007034 ()
  • 10850557007031 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-265
In Commercial Distribution

  • 00850798007633 ()
  • 00850798007640 ()
  • 00850798007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: AMP|BAR|BZO|COC300|MET500|MTD|OPI|OXY|PCP|THC
MERGERS MARKETING, INC.
PSC-DOA-4104M
In Commercial Distribution

  • 00851000007199 ()
  • 00851000007182 ()
  • 00851000007175 ()


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

  • 00857338006859 ()
  • 00857338006866 ()
FSCECOII-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/THC
HEMOSURE INC.
FSCW2974
In Commercial Distribution

  • 00857338006781 ()
  • 00841824102026 ()
FSCW2974

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

  • 00857338006644 ()
  • 00857338006736 ()
FSCECOII-3464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCECOII-564
In Commercial Distribution

  • 00857338006637 ()
  • 00857338006729 ()
FSCECOII-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCW874
In Commercial Distribution

  • 00857338006354 ()
  • 00841824101845 ()
FSCW874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCW174
In Commercial Distribution

  • 00857338006293 ()
  • 00841824102019 ()
FSCW174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/MTD/OPI/OXY/THC
W.H.P.M. INC.
W4494
In Commercial Distribution

  • 00841824105454 ()
  • 00841824105461 ()
W4494

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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/MOR/MTD/OXY/THC
W.H.P.M. INC.
W14104
In Commercial Distribution

  • 00841824103009 ()
  • 00841824100787 ()
W14104

  • 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.
W4104
In Commercial Distribution

  • 00841824102989 ()
  • 00841824100770 ()
W4104

  • 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/MOR/MTD/PCP/TCA/THC
W.H.P.M. INC.
W2104
In Commercial Distribution

  • 00841824102965 ()
  • 00841824100756 ()
W2104

  • 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
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
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
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
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
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 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 BZO/COC/MOR/MTD/OXY/THC
HEMOSURE INC.
FSCDIP1664
In Commercial Distribution

  • 00817763020707 ()
  • 00817763021391 ()
FSCDIP1664

  • 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
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