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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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
U-Screen Squared Integrated Cup 5 Panel Drug Screen for (THC/COC/OPI2000/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCup-5MB
Not in Commercial Distribution

  • 00858998006043 ()
USSCup-5MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET).
Instant Tech Subsidiary Acquisition
USSCup-4NT
Not in Commercial Distribution

  • 00858998006418 ()
USSCup-4NT

  • 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
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
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
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
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
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
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™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit
MICROBIOLOGICS INC.
8246-SPL
In Commercial Distribution

  • 70845357044388 ()
8246-SPL

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel
MICROBIOLOGICS INC.
8258
In Commercial Distribution

  • 70845357044197 ()
8258

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
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
QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8228
In Commercial Distribution

  • 70845357042681 ()
8228

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inactivated)
MICROBIOLOGICS INC.
8201
Not in Commercial Distribution

  • 70845357041486 ()
8201

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8181
In Commercial Distribution

  • 70845357041431 ()
8181

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8180
In Commercial Distribution

  • 70845357041424 ()
8180

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8189
In Commercial Distribution

  • 70845357041196 ()
8189

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8187
In Commercial Distribution

  • 70845357041172 ()
8187

  • Multiple bacteria carbapenemase nucleic acid IVD, control
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