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: BUP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7062-15
In Commercial Distribution

  • 00817830020975 ()

  • Length: 75 Millimeter
07RD7062-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7062-13
In Commercial Distribution

  • 00817830020968 ()

  • Length: 75 Millimeter
07RD7062-13

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

  • 00817830020876 ()

  • Length: 75 Millimeter
07RD7062-07

  • 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
RAPID DIAGNOSTICS INC
07RD7062-02
In Commercial Distribution

  • 00817830020784 ()

  • Length: 75 Millimeter
07RD7062-02

  • 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
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
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
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
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300, MTD, OPI2000, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3948
In Commercial Distribution

  • 00796918002426 ()
  • 10796918002423 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR, MTD, OXY, THC w/ADU
ALFA SCIENTIFIC DESIGNS, INC.
03-3803QW
In Commercial Distribution

  • 00796918002419 ()
  • 10796918002416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET, MOR300, MTD, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3942
In Commercial Distribution

  • 00796918002204 ()
  • 10796918002201 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR300, MTD, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3945
In Commercial Distribution

  • 00796918002198 ()
  • 10796918002195 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) AMP COC MET MOR PCP THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4703
In Commercial Distribution

  • 10796918001952 ()
  • 00796918001955 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP300, BAR, BZD, COC, MET, MOR300 MTD, TCA, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-6915
In Commercial Distribution

  • 10796918001730 ()
  • 00796918001733 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300, MTD, OXY100, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3932
In Commercial Distribution

  • 10796918001389 ()
  • 00796918001382 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300, MTD, TCA, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3924
In Commercial Distribution

  • 10796918001372 ()
  • 00796918001375 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300, MTD, PCP, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3917
In Commercial Distribution

  • 10796918001365 ()
  • 00796918001368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, PPX, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3916
In Commercial Distribution

  • 10796918001358 ()
  • 00796918001351 ()


  • Proctological operating table, hydraulic
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3910QW
In Commercial Distribution

  • 10796918001341 ()
  • 00796918001344 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3910
In Commercial Distribution

  • 10796918001334 ()
  • 00796918001337 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, TCA, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3909
In Commercial Distribution

  • 10796918001327 ()
  • 00796918001320 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, MTD, PCP, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3908
In Commercial Distribution

  • 10796918001310 ()
  • 00796918001313 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MultiDrug Test Cup 12; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA, THC
JANT PHARMACAL CORPORATION
DS932
In Commercial Distribution

  • 10763924932631 ()
  • 00763924932634 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MultiDrug Test Cup 12; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
JANT PHARMACAL CORPORATION
DS930
In Commercial Distribution

  • 10763924930637 ()
  • 00763924930630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Dip Test Card 12: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC.
JANT PHARMACAL CORPORATION
DS712
In Commercial Distribution

  • 10763924712639 ()
  • 00763924712632 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived)
JANT PHARMACAL CORPORATION
DS93S624
In Commercial Distribution

  • 10763924093639 ()
  • 00763924093632 ()
DS93S624

  • Multiple drugs of abuse IVD, kit, rapid ICT, 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
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 – 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
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
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
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, OXY, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5221
In Commercial Distribution

  • 00847817000386 ()
1945221

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
Lifesign L.L.C.
76025AA2K
In Commercial Distribution

  • 00868348000249 ()
76025AA2K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup
Twin Spirit Inc.
61230D
Not in Commercial Distribution

  • 00859144006221 ()
61230D

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