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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Areta 5 Panel Drug Test Cup (100 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007550 ()
  • 30855944007551 ()
ACDOA-754-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (50 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007543 ()
  • 30855944007544 ()
ACDOA-754-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (10 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007536 ()
  • 30855944007537 ()
ACDOA-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 10855944007274 ()
  • 00855944007277 ()
  • 30855944007278 ()
ACDOA-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (5 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007260 ()
  • 30855944007261 ()
  • 10855944007267 ()
ACDOA-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The E-Series Spindle Hybrid Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171155 ()
LES000019

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171056 ()
LES000007

  • Medical monitor/light mount
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-154
In Commercial Distribution

  • 10851000007141 ()
  • 00851000007144 ()
  • 00851000007137 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
CSC-654
In Commercial Distribution

  • 10850557007871 ()
  • 00850557007874 ()
  • 00850557007867 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
CSC-254
In Commercial Distribution

  • 10850557007833 ()
  • 00850557007836 ()
  • 00850557007829 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PSC-DOA-654
In Commercial Distribution

  • 00850557007546 ()
  • 10850557007550 ()
  • 00850557007553 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-254
In Commercial Distribution

  • 00850557007423 ()
  • 00850557007430 ()
  • 10850557007437 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000392 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000361 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL
Ls Enterprises, Inc.
2184BC
In Commercial Distribution

  • D0692184BC0 ()


  • Dental delivery system
QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI
UCP BIOSCIENCES, INC.
U-CUP-264
In Commercial Distribution

  • 20817038022232 ()
  • 10817038022235 ()
  • 00817038022238 ()
U-CUP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 6 Panel Dip Card AMP/COC/THC/MET/BZO/OPI
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038022157 ()
  • 10817038022150 ()
  • 00817038022153 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 panel Test Card AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-4104L
In Commercial Distribution

  • 20817038021167 ()
  • 10817038021160 ()
  • 00817038021163 ()
U-DOA-4104L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP
UCP BIOSCIENCES, INC.
U-CUP-184-RCN
In Commercial Distribution

  • 20817038020665 ()
  • 10817038020668 ()
  • 00817038020661 ()
U-CUP-184-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 01812125010067 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
PANEL 12 COC/AMP/M-AMP/THC/MTD/MDMA/ OPI/OXY/PPX/PCP/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020141
In Commercial Distribution

  • 10858904006461 ()
  • 00858904006464 ()
DOA-1124-051

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/P CP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020184
In Commercial Distribution

  • 10858904006416 ()
  • 00858904006419 ()
DOA-1114-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/P CP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020183
In Commercial Distribution

  • 10858904006409 ()
  • 00858904006402 ()
DOA-1104-751

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-184-RCN
In Commercial Distribution

  • 10850721007034 ()
  • 00850721007037 ()
  • 20850721007031 ()
U-CUP-184-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Drug Test Card BZO/COC/THC/mAMP/MOP/MTD/OXY/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-DOA-394
In Commercial Distribution

  • 10850721007010 ()
  • 00850721007013 ()
  • 20850721007017 ()
U-DOA-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Drug Test Card BZO/BAR/COC/mAMP/MOP/MTD/OXY/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-DOA-294
In Commercial Distribution

  • 10850721007003 ()
  • 00850721007006 ()
  • 20850721007000 ()
U-DOA-294

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
T2 BIOSYSTEMS, INC.
80-08072
In Commercial Distribution

  • M70880080720 ()
  • M70880080723 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
80-07342
In Commercial Distribution

  • M70880073423 ()
  • M70880050580 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
80-01689
In Commercial Distribution

  • M70880016893 ()
  • M70880009660 ()


  • Multiple Candida species nucleic acid IVD, reagent
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
IDUN SOLUTIONS LLC
41511104001034
In Commercial Distribution

  • 90857275007837 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel
MICROBIOLOGICS INC.
8242
In Commercial Distribution

  • 70845357044180 ()
8242

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel
MICROBIOLOGICS INC.
8249
In Commercial Distribution

  • 70845357043732 ()
8249

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8246
In Commercial Distribution

  • 70845357043602 ()
8246

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8236
In Commercial Distribution

  • 70845357043060 ()
8236

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory (4 Targets) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8233
Not in Commercial Distribution

  • 70845357042742 ()
8233

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
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