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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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
Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC with Adulterants
MERGERS MARKETING, INC.
CSC-264AD
In Commercial Distribution

  • 00851000007328 ()
  • 00851000007335 ()
  • 10851000007332 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
CSC-8104
In Commercial Distribution

  • 00850557007942 ()
  • 00850557007959 ()
  • 10850557007956 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-4104
In Commercial Distribution

  • 00850557007928 ()
  • 00850557007935 ()
  • 10850557007932 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
CSC-3104
In Commercial Distribution

  • 00850557007904 ()
  • 00850557007911 ()
  • 10850557007918 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
PSC-DOA-8104
In Commercial Distribution

  • 00850557007669 ()
  • 00850557007676 ()
  • 10850557007673 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7104
In Commercial Distribution

  • 00850557007621 ()
  • 00850557007638 ()
  • 10850557007635 ()


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

  • 00850557007584 ()
  • 00850557007591 ()
  • 10850557007598 ()


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

  • 00850557007508 ()
  • 00850557007515 ()
  • 10850557007512 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-7104
In Commercial Distribution

  • 00850557007348 ()
  • 00850557007355 ()
  • 10850557007352 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-285T
In Commercial Distribution

  • 00850798007626 ()
  • 00850798007619 ()
  • 00850798007602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
CHEMTRON BIOTECH INC
KCUR920083
In Commercial Distribution

  • 00850019007855 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12 CLIA-Waived, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA - 25 tests/kit
CHEMTRON BIOTECH INC
C-61203D
In Commercial Distribution

  • 00850019007770 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Dual Chamber Cup, AMP300/BAR200/BUP10/BZO200/ COC150/MDMA/MET300/MTD300/OPI300/OXY/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L07D
In Commercial Distribution

  • 00850019007701 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET500/MTD/OPI300/OXY/PCP/PPX/TCA/THC - Chemtrue, 25tests/kit
CHEMTRON BIOTECH INC
712M03-CT
In Commercial Distribution

  • 00850019007619 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12, COC/THC/MET/OPI2000/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP - Clia Waived, 25tests/kit
CHEMTRON BIOTECH INC
C-61205D
In Commercial Distribution

  • 00850019007596 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 13 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
CHEMTRON BIOTECH INC
C31303D
In Commercial Distribution

  • 00850019007473 ()
C31303D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screen Cup Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L03
In Commercial Distribution

  • 00850019007428 ()
712L03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET/AMP/PCP/BZO/BAR/MTD/OXY/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711K01
In Commercial Distribution

  • 00850019007398 ()
711K01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl), 25 tests/kit
CHEMTRON BIOTECH INC
KCUR920080
In Commercial Distribution

  • 00850019007893 ()


  • 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 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
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 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
Identify® Diagnostics-Home Drug Testing Device Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007420 ()
  • 10850721007423 ()
  • 00850721007426 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify ® -Home Drug Testing Device Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007413 ()
  • 10850721007416 ()
  • 00850721007419 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 14 Panel THC/COC/PCP/mAMP/AMP/MDMA/TCA/BAR/BZO/MTD/OXY/PPX/BUP/OPI
RITE AID CORPORATION
8024512
In Commercial Distribution

  • 00011822001670 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Propoxyphene IVD, reagent
  • Nortriptyline IVD, reagent
u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
UCP BIOSCIENCES, INC.
UDO-6123
In Commercial Distribution

  • 20817038021907 ()
  • 10817038021900 ()
  • 00817038021903 ()
UDO-6123

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Cup Drug Test Screen 10 Panel Drug Test Cup (BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC)
UCP BIOSCIENCES, INC.
U-CUP-7104
In Commercial Distribution

  • 20817038021860 ()
  • 10817038021863 ()
  • 00817038021866 ()
U-CUP-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML
In Commercial Distribution

  • 20817038021754 ()
  • 10817038021757 ()
  • 00817038021750 ()
UCC-12-1ML

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1M
In Commercial Distribution

  • 20817038021747 ()
  • 10817038021740 ()
  • 00817038021743 ()
UCC-12-1M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-8134-RCN
In Commercial Distribution

  • 20817038020641 ()
  • 10817038020644 ()
  • 00817038020647 ()
U-CUP-8134-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 11 Panel Oral Fluid Drug Test FYL AMP COC MET OPI THC BAR BZO MDMA OXY PCP
Mlife Diagnostics, LLC
MV002.11.0001EI
In Commercial Distribution

  • G474MV002110001EI0 ()


  • 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
DOA 8 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP500/BUP/BZO/COC150/MTD/OPI/OXY/THC
W.H.P.M. INC.
W3884
In Commercial Distribution

  • 00841824104761 ()
  • 10841824104768 ()
W3884

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