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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Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ10
In Commercial Distribution

  • 20850721007611 ()
  • 10850721007614 ()
  • 00850721007617 ()
ID-CP5-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify ®Diagnostics Drug Test Cups 5-Panel Drug Screening Test Cup THC/OXY/MOP/BZO/COC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5
In Commercial Distribution

  • 20850721007567 ()
  • 10850721007560 ()
  • 00850721007563 ()
ID-CP5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ5
In Commercial Distribution

  • 20850721007505 ()
  • 10850721007508 ()
  • 00850721007501 ()
ID-CP5-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-EDDP
In Commercial Distribution

  • 20850721007383 ()
  • 10850721007386 ()
  • 00850721007389 ()
ID-CP12-EDDP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-6104-RCN
In Commercial Distribution

  • 20850721007055 ()
  • 10850721007058 ()
  • 00850721007051 ()
U-CUP-6104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Siemens Healthcare Diagnostics Inc.
10445363
In Commercial Distribution

  • 00842768001345 ()
  • 00630414013978 ()
6A289UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/OXY/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA13051 ()
  • B115ABCUPA13050 ()
ABCupA-13-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA13011 ()
  • B115ABCUPA13010 ()
ABCupA-13-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/OXY/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA13051 ()
  • B115ABCARDA13050 ()
ABCardA-13-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA13011 ()
  • B115ABCARDA13010 ()
ABCardA-13-01

  • 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
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
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
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
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
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
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
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
12-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/MDMA/MET500/MTD/MOR/OXY/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L11D
In Commercial Distribution

  • 00850019007978 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 11, AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP, 25tests/kit, CLIA-Waived
CHEMTRON BIOTECH INC
61127D
In Commercial Distribution

  • 00850019007688 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12, THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY, 25test/kit
CHEMTRON BIOTECH INC
61230D
In Commercial Distribution

  • 00850019007602 ()


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