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 8 in 1 Test Dip Card, Sealed Pouch, CLIA Waived, AMP/COC150/mAMP500/MDMA/OPI/OXY/PCP/THC
W.H.P.M. INC.
W3684
In Commercial Distribution

  • 00841824104525 ()
  • 00841824104532 ()
W3684P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BUP/BZO/COC/EDDP/MDMA/MOR/THC
W.H.P.M. INC.
W1384
In Commercial Distribution

  • 00841824104044 ()
  • 00841824104051 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/MOR/PCP/THC
W.H.P.M. INC.
ECOII-4574
In Commercial Distribution

  • 00841824103986 ()
  • 00841824103993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
ECOII-984
In Commercial Distribution

  • 00841824103849 ()
  • 00841824103856 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
ECOII-184
In Commercial Distribution

  • 00841824103818 ()
  • 00841824103832 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
ECOII-874
In Commercial Distribution

  • 00841824103375 ()
  • 00841824103405 ()
ECOII-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/MOR/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP454 W/AD
In Commercial Distribution

  • 00841824103269 ()
  • 00841824103276 ()
WECCUP454 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dipcard, 25Pcs/Box, Clia Waived AMP/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
W1094
In Commercial Distribution

  • 00841824102903 ()
  • 00841824100695 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/THC
W.H.P.M. INC.
W194
In Commercial Distribution

  • 00841824102897 ()
  • 00841824100688 ()
W194

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP254 W/AD
In Commercial Distribution

  • 00841824101944 ()
  • 00841824101357 ()
WECCUP254W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/COC/mAMP/MDMA/OPI/PCP/THC
W.H.P.M. INC.
ECOII-674
In Commercial Distribution

  • 00841824101739 ()
  • 00841824101746 ()
ECOII-674

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/OXY/THC
W.H.P.M. INC.
ECOⅡ-174
In Commercial Distribution

  • 00841824101166 ()
  • 00841824101531 ()
ECOⅡ-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP354 W/AD
In Commercial Distribution

  • 00841824101074 ()
  • 00841824101432 ()
WECCUP354 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007413 ()
  • 30855944007414 ()
  • 10855944007410 ()
EDOAP-295-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007406 ()
  • 30855944007407 ()
EDOAP-295-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007390 ()
  • 30855944007391 ()
EDOAP-295-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
EASY HEALTHCARE CORPORATION
EDOAP-295
In Commercial Distribution

  • 00855944007383 ()
  • 30855944007384 ()
EDOAP-295-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61060D-6AB
In Commercial Distribution

  • 00812203030780 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/COC/THC/OPI2000/MET/PCP/BAR/BZO/MTD/OXY + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61020D-6AB
In Commercial Distribution

  • 00812203030612 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-ALT
In Commercial Distribution

  • 00812203030490 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-LC
In Commercial Distribution

  • 00812203030353 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit
CHEMTRON BIOTECH INC
712M06
In Commercial Distribution

  • 00812203030056 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712G03A
In Commercial Distribution

  • 00812203030025 ()


  • 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 / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Azure Biotech, Inc.
AZC-8105
In Commercial Distribution

  • 00810022630402 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
Quest Diagnostics
UDOA-6CA-0503-01
In Commercial Distribution

  • 00869419000205 ()
  • 20869419000209 ()
DUA-167-012-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 7 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2277-0-A
In Commercial Distribution

  • 00816036027122 ()
  • 00816036026620 ()
SCP-2277-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-2124-0
In Commercial Distribution

  • 00816036025944 ()
  • 00816036026422 ()
SDP-2124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BUP/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-6124-0
In Commercial Distribution

  • 00816036025937 ()
  • 00816036026415 ()
SDP-6124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/PPX/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1124-0
In Commercial Distribution

  • 00816036025920 ()
  • 00816036026408 ()
SDP-1124-0

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

  • 00816036025166 ()
  • 00816036025326 ()
FST-71127-0

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

  • 00816036025074 ()
  • 00816036025234 ()
STATⅡ-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2167-A
In Commercial Distribution

  • 00816036021311 ()
  • 00816036021496 ()
SCP-2167-A

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

  • 00816036021281 ()
  • 00816036021465 ()
SCP-1257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box THC/COC/OPI/mAMP/PCP/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-3257-A
In Commercial Distribution

  • 00816036021267 ()
  • 00816036021441 ()
SCP-3257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-6157-A
In Commercial Distribution

  • 00816036021243 ()
  • 00816036021427 ()
SCP-6157-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-184
In Commercial Distribution

  • 00816036020321 ()
  • 00816036020710 ()
SDP-184

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-7P
Not in Commercial Distribution

  • 00816565020250 ()
IMCA-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-5AB-W
Not in Commercial Distribution

  • 00816565020205 ()
IMCA-5AB-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Benzodiazepines, Barbiturate, Cocaine and THC metabolites in urine.
BTNX Inc
D12.8-1P29-25
In Commercial Distribution

  • 00722066003671 ()
  • 00722066004081 ()
D12.8-1P29-25

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