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 panel CLIA Waived Urine Dip Card AMP1000, COC300,OPI2000,PCP25,THC50
Instant Technologies, Inc.
ABTDOAW105401A
In Commercial Distribution

  • 30817405024002 ()
  • 00817405024001 ()
  • 10817405024008 ()
ABTDOAW105401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10
Instant Technologies, Inc.
ABTOFCUBE0603C
In Commercial Distribution

  • 30817405023548 ()
  • 00817405023547 ()
  • 10817405023544 ()
ABTOFCUBE0603C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0602B
In Commercial Distribution

  • 30817405023531 ()
  • 00817405023530 ()
  • 10817405023537 ()
ABTOFCUBE0602B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0601A
In Commercial Distribution

  • 30817405023524 ()
  • 00817405023523 ()
  • 10817405023520 ()
ABTOFCUBE0601A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 01812125010074 ()
AC043

  • Specimen processing instrument IVD
8 panel test cup, (COC/THC)+AMP+BZO+BUP+MET1000+MTD+OPI300
AMEDITECH INC.
IMC-8BB
Not in Commercial Distribution

  • 00816565020175 ()
IMC-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup;+Adulterant Test Strips CR/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-8105A3A
In Commercial Distribution

  • 20816490023108 ()
  • 10816490023101 ()
  • 00816490023104 ()
HCDOAEW-8105A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup;+Adulterant Test Strips CR/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-6125A3A
In Commercial Distribution

  • 20816490023078 ()
  • 10816490023071 ()
  • 00816490023074 ()
HCDOAEW-6125A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-6124A3
In Commercial Distribution

  • 20816490021968 ()
  • 10816490021961 ()
  • 00816490021964 ()
HCDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup + Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAF-6125A3
In Commercial Distribution

  • 20816490021425 ()
  • 10816490021428 ()
  • 00816490021421 ()
HCDOAF-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-8105A3
In Commercial Distribution

  • 20816490021227 ()
  • 10816490021220 ()
  • 00816490021223 ()
HCDOA-8105A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-1104SA3
In Commercial Distribution

  • 20816490021203 ()
  • 10816490021206 ()
  • 00816490021209 ()
HCDOA-1104SA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup ;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-254A3
In Commercial Distribution

  • 20816490021180 ()
  • 10816490021183 ()
  • 00816490021186 ()
HCDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Flat Cup + Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAF-254A3
In Commercial Distribution

  • 20816490020695 ()
  • 10816490020698 ()
  • 00816490020691 ()
HCDOAF-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, BZO/COC/mAMP/MOR/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0
In Commercial Distribution

  • 00816036027146 ()
  • 00816036026644 ()
SCP-6157-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, COC/mAMP/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0
In Commercial Distribution

  • 00816036026521 ()
  • 00816036027023 ()
SCP-3257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-1257-0
In Commercial Distribution

  • 00816036026507 ()
  • 00816036027009 ()
SCP-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 6 Panel Dip Card, CLIA AMP1000/BZO300/COC300/mAMP1000/MOP2000
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002813 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-564
In Commercial Distribution

  • 00895330002967 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Home Drug Test 7 Panel THC/COC/OPI/PCP/mAMP/AMP/MDMA
RITE AID CORPORATION
8024511
In Commercial Distribution

  • 00011822001694 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Curetis GmbH
QIAGEN® EZ1® Advanced XL System
Not in Commercial Distribution

62005

  • Specimen processing instrument IVD
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
MX50YQS
In Commercial Distribution

  • 08809241513087 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
CX50YQS
In Commercial Distribution

  • 08809241513070 ()


  • Image display unit, colour
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ25
In Commercial Distribution

  • 20850721007710 ()
  • 10850721007713 ()
  • 00850721007716 ()
ID-THC-DIP-AZ25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ10
In Commercial Distribution

  • 20850721007598 ()
  • 10850721007591 ()
  • 00850721007594 ()
ID-THC-DIP-AZ10

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007475 ()
  • 10850721007478 ()
  • 00850721007471 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ5
In Commercial Distribution

  • 20850721007468 ()
  • 10850721007461 ()
  • 00850721007464 ()
ID-THC-DIP-AZ5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-664-RCN
In Commercial Distribution

  • 20850721007116 ()
  • 10850721007119 ()
  • 00850721007112 ()
U-CUP-664-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards THC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP-AZ15
In Commercial Distribution

  • 20850721007871 ()
  • 10850721007874 ()
  • 00850721007877 ()
ID-THC-DIP-AZ15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6 Panel Drug Screening Test Cup BZO/COC/OPI300/MTD/OXY/BUP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-964-RCN
In Commercial Distribution

  • 20850721007048 ()
  • 10850721007041 ()
  • 00850721007044 ()
U-CUP-964-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card TM Drug Test Screen 3 panel Test Card COC/MET/THC
UCP BIOSCIENCES, INC.
U-DOA-234L
In Commercial Distribution

  • 20817038021952 ()
  • 10817038021955 ()
  • 00817038021958 ()
U-DOA-234L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114
In Commercial Distribution

  • 20817038021914 ()
  • 10817038021917 ()
  • 00817038021910 ()
U-MDMA-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards AMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-AMP-114
In Commercial Distribution

  • 20817038021570 ()
  • 10817038021573 ()
  • 00817038021576 ()
U-AMP-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards PCP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-PCP-114
In Commercial Distribution

  • 20817038021563 ()
  • 10817038021566 ()
  • 00817038021569 ()
U-PCP-114

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards MTD Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MTD-114
In Commercial Distribution

  • 20817038021549 ()
  • 10817038021542 ()
  • 00817038021545 ()
U-MTD-114

  • Methadone IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114
In Commercial Distribution

  • 20817038021525 ()
  • 10817038021528 ()
  • 00817038021521 ()
U-MDMA-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards mAMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MET-114
In Commercial Distribution

  • 20817038021518 ()
  • 10817038021511 ()
  • 00817038021514 ()
U-MET-114

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114
In Commercial Distribution

  • 20817038021501 ()
  • 10817038021504 ()
  • 00817038021507 ()
U-COC-114

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards BZO Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BZO-114
In Commercial Distribution

  • 20817038021495 ()
  • 10817038021498 ()
  • 00817038021491 ()
U-BZO-114

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114
In Commercial Distribution

  • 20817038021488 ()
  • 10817038021481 ()
  • 00817038021484 ()
U-BAR-114

  • Barbiturate IVD, kit, rapid ICT, clinical
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