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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Immunoassay for the detection of the following drug substance(s) in human urine: THC / COC / AMP
RAPID DIAGNOSTICS INC
07RD7109-02
In Commercial Distribution

  • 00817830020289 ()

  • Height: 74 Millimeter
07RD7109-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-5M
Not in Commercial Distribution

  • 00817405020775 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MTD/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-194-0
In Commercial Distribution

  • 00816036025821 ()
  • 00816036026309 ()
SDP-194-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATII-4267-0
In Commercial Distribution

  • 00816036025388 ()
  • 00816036025395 ()
STATII-4267-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup W/AD, AMP/COC/mAMP/OPI/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-1257-0-A
In Commercial Distribution

  • 00816036025012 ()
  • 00816036025180 ()
STATⅡ-1257-0-A

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

  • 00816036021274 ()
  • 00816036021458 ()
SCP-6157

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

  • 00816036021250 ()
  • 00816036021434 ()
SCP-1257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in1 Test Dipcard, 25Pcs/Box BAR/BZO/COC/mAMP/MOR/MTD/OXY/THC
MICRO DISTRIBUTING, L.C
SDP-384
In Commercial Distribution

  • 00816036020314 ()
  • 00816036020703 ()
SDP-384

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in1 CLIA Waived Test Dipcard, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
MICRO DISTRIBUTING, L.C
SDP-364
In Commercial Distribution

  • 00816036020291 ()
  • 00816036020673 ()
SDP-364

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-264
In Commercial Distribution

  • 00816036020284 ()
  • 00816036020666 ()
SDP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SDP-254-A
In Commercial Distribution

  • 00816036020239 ()
  • 00816036020611 ()
SDP-254-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/BZO/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-654
In Commercial Distribution

  • 00816036020208 ()
  • 00816036020581 ()
SDP-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET1000/OPI2000/THC multiple drugs dipcard with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMDA-5M
Not in Commercial Distribution

  • 00816565020113 ()
IMDA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
AMEDITECH INC.
C-60B02
Not in Commercial Distribution

  • 00816565020595 ()
C-60B02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
TDOA-1144
In Commercial Distribution

  • 10816862020059 ()
  • 00816862020052 ()
  • 00816862029055 ()
TDOA-1144

  • 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
WONDFO USA CO., LTD.
CDOA-2135
In Commercial Distribution

  • 10816862026372 ()
  • 00816862026375 ()
  • 00816862026368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Preview Panel,AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-WDOA-6124
In Commercial Distribution

  • 00816862021707 ()
  • 00816862021691 ()
  • 10816862021704 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-WDOA-6125
In Commercial Distribution

  • 10816862021483 ()
  • 00816862021486 ()
  • 00816862028485 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card for Cup; AMP,BAR,BUP,BZO,COC,MDMA,MTD,TCA,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-3124A
In Commercial Distribution

  • 10816862021308 ()
  • 00816862021301 ()
  • 00816862028300 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
TDOA-1144
In Commercial Distribution

  • 00816862025057 ()
TDOA-1144

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,THC
WONDFO USA CO., LTD.
PRE-WDOA-1124
In Commercial Distribution

  • 00816862022230 ()
  • 00816862022247 ()
  • 10816862022237 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel CR3 Split Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
CRDOA-6125
In Commercial Distribution

  • 00816862021066 ()
  • 00816862028065 ()
  • 10816862021063 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-04
In Commercial Distribution

  • M90107RD7062041 ()
  • M90107RD7062040 ()

  • Length: 75 Millimeter
07RD7062-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC
CHEMTRON BIOTECH INC
712M09-G
In Commercial Distribution

  • 00812203030797 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 7, AMP500/COC150/MET500/MDMA/THC/OXY/OPI + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
60775D-6AB
In Commercial Distribution

  • 00812203030599 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
CHEMTRON BIOTECH INC
PCA-10X3X-ALT
In Commercial Distribution

  • 00812203030506 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP500/BAR/BZO/COC150/MET500/MTD/MOR/PCP/PPX/THC(Cr/Ox/pH)
CHEMTRON BIOTECH INC
712J10A-G
In Commercial Distribution

  • 00812203030254 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI300/PCP/PPX/THC(Cr/SG/Bl)
CHEMTRON BIOTECH INC
712J09A-G
In Commercial Distribution

  • 00812203030209 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel DOA Cup, COC/THC/OPI2000/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit
CHEMTRON BIOTECH INC
712C04A
In Commercial Distribution

  • 00812203030001 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
EASY HEALTHCARE CORPORATION
EDOAP-3104
In Commercial Distribution

  • 30810038631371 ()
  • 00810038631370 ()
EDOAP-3104-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50
SYNTRON BIORESEARCH, INC.
60510
In Commercial Distribution

  • 20748349000117 ()
  • 10748349000110 ()
  • 00748349000113 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN Multi 5 Drug Cup Test – BUP 10, BZD 300, COC 300, OPI 2000, THC 50
SYNTRON BIORESEARCH, INC.
60568
In Commercial Distribution

  • 20748349000407 ()
  • 10748349000400 ()
  • 00748349000403 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QUIKSCREEN MULTI 5 DRUG CUP TEST - BZD 300, COC 300, MET 1000, OPI 300, THC 50
SYNTRON BIORESEARCH, INC.
60554
In Commercial Distribution

  • 20748349000285 ()
  • 10748349000288 ()
  • 00748349000281 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
PRIME SCREEN® Marijuana (THC) Urine Test Strip, 20 Tests per Box with Plastic Urine Cups
WONDFO USA CO., LTD.
DWDTH-101-20BX-CUP-A
In Commercial Distribution

  • 10816862027324 ()
  • 00816862027327 ()
  • 00816862027310 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
Five Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-254AD
In Commercial Distribution

  • 00850557007447 ()
  • 00850557007454 ()
  • 10850557007451 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Seven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-274
In Commercial Distribution

  • 00850557007188 ()
  • 00850557007195 ()
  • 10850557007192 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 10850253007564 ()
  • 00850253007567 ()
  • 30850253007568 ()


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