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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15 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007328 ()
  • 00850253007321 ()
  • 30850253007322 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007311 ()
  • 00850253007314 ()
  • 30850253007315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit; 5-Panel Dip Cards; AMP/BZO/COC/OPI/THC
IDUN SOLUTIONS LLC
IDOA-755-5P
Not in Commercial Distribution

  • 00857275007131 ()
  • 00857275007032 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10855944007458 ()
  • 00855944007451 ()
  • 30855944007452 ()
EDOAP-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;THC/COC/OPI/BZO/MET
EASY HEALTHCARE CORPORATION
EDOAP-654
In Commercial Distribution

  • 10855944007038 ()
  • 00855944007031 ()
  • 30855944007032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Amazewell™ D-Pen™ Mini THC Oral Fluid Test, 10T/Box
Guangzhou Decheng Biotechnology Co., LTD
DPM-THC-10B
In Commercial Distribution

  • 30850054867033 ()
  • 00850054867032 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR MM5CPCP
In Commercial Distribution

  • 10850011007027 ()
  • 00850011007020 ()
  • 20850011007024 ()
TNR MM5CPCP

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC
MERCEDES MEDICAL, LLC
TNR MM5CMET
In Commercial Distribution

  • 20850011007017 ()
  • 10850011007010 ()
  • 00850011007013 ()
TNR MM5CMET

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, liquid chromatography
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
4-Panel DOA Dip Card, COC/THC/MET/AMP, 25 tests/kit
CHEMTRON BIOTECH INC
711D02
In Commercial Distribution

  • 00850019007909 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 5, AMP/COC/OPI/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60505D
In Commercial Distribution

  • 00850019007664 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6, AMP/COC/THC/OPI2000/MET/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
C60620
In Commercial Distribution

  • 00850019007480 ()
C60620

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711C02
In Commercial Distribution

  • 00850019007275 ()
711C02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
60620D
In Commercial Distribution

  • 00850019007121 ()
60620D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 6, AMP/BAR/BZO/COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30620D
In Commercial Distribution

  • 00850019007091 ()
30620D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 6, AMP/BZO/COC/MET/OPI2000/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30600D
In Commercial Distribution

  • 00850019007084 ()
30600D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/BZO/OPI/MET drugs of abuse test cup
Twin Spirit Inc.
60600D
Not in Commercial Distribution

  • 00859144006177 ()
60600D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/MET/OPI/OXY drugs of abuse test cup
Twin Spirit Inc.
60620D
Not in Commercial Distribution

  • 00859144006160 ()
60620D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
Instant Tech Subsidiary Acquisition
PSD-6MBO
Not in Commercial Distribution

  • 00858998006838 ()
PSD-6MBO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSDip-6MB
Not in Commercial Distribution

  • 00858998006197 ()
USSDip-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/MAMP/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSDip-6BO
Not in Commercial Distribution

  • 00858998006005 ()
USSDip-6BO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP, BZO, COC, MET, OPI, THC drugs of abuse test cup
NEXSCREEN, LLC
C-60613N
In Commercial Distribution

  • 00858984006170 ()
C-60613N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC
Instant Tech Subsidiary Acquisition
PSD-6MP
Not in Commercial Distribution

  • 00858998006845 ()
PSD-6MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
Instant Tech Subsidiary Acquisition
PSD-6MB
Not in Commercial Distribution

  • 00858998006821 ()
PSD-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/BZO/COC/OPI2000/OXY/THC
Instant Tech Subsidiary Acquisition
PSCup-6BO-W
Not in Commercial Distribution

  • 00858998006517 ()
PSCup-6BO-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Number One 5-Panel Drug Test Cup OPI/COC/MET/AMP/THC
UCP BIOSCIENCES, INC.
N1T-1105-P
In Commercial Distribution

  • 20817038022195 ()
  • 10817038022198 ()
  • 00817038022191 ()
N1T-1105-P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
UCP BIOSCIENCES, INC.
U-DOA-134
In Commercial Distribution

  • 20817038022126 ()
  • 10817038022129 ()
  • 00817038022122 ()
U-DOA-134

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6-Panel Drug Test Mini Cup BZO/COC/THC/OXY/OPI300/AMP
UCP BIOSCIENCES, INC.
U-MCUP-664-POC
In Commercial Distribution

  • 20817038020740 ()
  • 10817038020743 ()
  • 00817038020746 ()
U-MCUP-664-POC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/THC/OPI300/OXY/BUP
UCP BIOSCIENCES, INC.
U-CUP-1454-RCN
In Commercial Distribution

  • 20817038020610 ()
  • 10817038020613 ()
  • 00817038020616 ()
U-CUP-1454-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038020481 ()
  • 10817038020484 ()
  • 00817038020487 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/AMP/mAMP/THC/OPI)
ALERE SAN DIEGO, INC.
DOA-254
In Commercial Distribution

  • 10815845020642 ()
  • 00815845020645 ()
4012110099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC150/AMP300/BZO/MAMP500/MDMA/OPI300/OXY/PCP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020181
In Commercial Distribution

  • 10858904006386 ()
  • 00858904006389 ()
DOA-194-291

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020180
In Commercial Distribution

  • 10858904006379 ()
  • 00858904006372 ()
DOA-194-281

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

  • 20850721007338 ()
  • 10850721007331 ()
  • 00850721007334 ()
ID-CP6

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

  • 20850721007222 ()
  • 10850721007225 ()
  • 00850721007228 ()
ID-CP6-AZ5

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

  • 20850721007130 ()
  • 10850721007133 ()
  • 00850721007136 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
MEDICAL DISTRIBUTION GROUP INC
U-CUP-1254-RCN
In Commercial Distribution

  • 20850721007109 ()
  • 10850721007102 ()
  • 00850721007105 ()
U-CUP-1254-RCN

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

  • 20850721007093 ()
  • 10850721007096 ()
  • 00850721007099 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002653 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3551
In Commercial Distribution

  • 10796918002188 ()
  • 00796918002181 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6577
In Commercial Distribution

  • 10796918001631 ()
  • 00796918001634 ()


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