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 urine cup that tests for (THC-COC-OPI-AMP-MET) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALL254R
In Commercial Distribution

  • 00861272000316 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104
In Commercial Distribution

  • 00895330002738 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/BAR/OXY/MDMA/PPX
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-2104
In Commercial Distribution

  • 00895330002714 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 5 Panel Dip Card - CLIA Waived - BZO300/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-654
In Commercial Distribution

  • 00895330002646 ()


  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
PANEL 11 COC150/AMP300/MAMP500/BAR/BZO/OPI300/MDMA/OXY/PCP/MTD/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020187
In Commercial Distribution

  • 10858904006454 ()
  • 00858904006457 ()
DOA-1114-131

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/PPX/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020186
In Commercial Distribution

  • 10858904006447 ()
  • 00858904006440 ()
DOA-1114-121

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 6 Panel DOA Cup (6.65) - AMP1000, BUP10, BZO300, COC300, OPI2000, OXY100
BTNX Inc
D6.65-1V
In Commercial Distribution

  • 10722066008345 ()
  • 00722066008348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel E&I Oral Click Cube AMP50, BZO10, COC20, MET50, OPI40, OXY20
Instant Technologies, Inc.
ABTOFCUBE0604D
In Commercial Distribution

  • 30817405023937 ()
  • 00817405023936 ()
  • 10817405023933 ()
ABTOFCUBE0604D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW17701A
In Commercial Distribution

  • 30817405023333 ()
  • 00817405023332 ()
  • 10817405023339 ()
ABTDOAW17701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0701A
In Commercial Distribution

  • 30817405023555 ()
  • 00817405023554 ()
  • 10817405023551 ()
ABTOFCUBE0701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATII-6357-0
In Commercial Distribution

  • 00816036025029 ()
  • 00816036025197 ()
STATII-6357-0

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

  • 00816036025005 ()
  • 00816036025173 ()
STATⅡ-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup + Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAF-22105SA3
In Commercial Distribution

  • 10816490024085 ()
  • 00816490024088 ()
  • 20816490024082 ()
HCDOAF-22105SA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup ; +Adulterant Test Strips (CRE/SG/pH)
Healgen Scientific Limited Liability Company
HCDOAV-6125A3A
In Commercial Distribution

  • 20816490020992 ()
  • 10816490020995 ()
  • 00816490020998 ()
HCDOAV-6125A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup + Adulterant Test Strips OXI/SG/CRE
Healgen Scientific Limited Liability Company
HCDOAF-6125A3C
In Commercial Distribution

  • 20816490021579 ()
  • 10816490021572 ()
  • 00816490021575 ()
HCDOAF-6125A3C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Multiplex Vaginal Control Panel
MICROBIOLOGICS INC.
8255
In Commercial Distribution

  • 70845357044128 ()
8255

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Mycoplasma genitalium Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8240
Not in Commercial Distribution

  • 70845357043053 ()
8240

  • Mycoplasma genitalium nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8227
In Commercial Distribution

  • 70845357042711 ()
8227

  • Clostridium difficile nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8230
In Commercial Distribution

  • 70845357042698 ()
8230

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
MICROBIOLOGICS INC.
8219
In Commercial Distribution

  • 70845357041493 ()
8219

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution

  • 70845357041448 ()
8184

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8190
In Commercial Distribution

  • 70845357041202 ()
8190

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Gram-Positive Blood Culture Control Panel (Live Culture)
MICROBIOLOGICS INC.
5225P
In Commercial Distribution

  • 70845357037342 ()
5225P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Gram-Negative Blood Culture Control Panel (Live Culture)
MICROBIOLOGICS INC.
5226P
Not in Commercial Distribution

  • 70845357037335 ()
5226P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Dried Overnight – Gram Positive Panel QC Set
MICROBIOLOGICS INC.
5063P
In Commercial Distribution

  • 70845357025592 ()
5063P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Dried Overnight – Gram Negative Panel QC Set
MICROBIOLOGICS INC.
5062P
In Commercial Distribution

  • 70845357025561 ()
5062P

  • Multiple bacteria species culture isolate identification control IVD, kit
6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
CHEMTRON BIOTECH INC
PCA-6M2S-20
In Commercial Distribution

  • 00812203030582 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
CHEMTRON BIOTECH INC
PCA-6M2SC-LC
In Commercial Distribution

  • 00812203030575 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CVi Injector p/n 800620-023 Contents: CVi Injector Head, Control Panel, & Power Supply
ACIST MEDICAL SYSTEMS, INC.
014657
In Commercial Distribution

  • 40841716101876 ()


  • Angiography contrast medium injection system, line-powered, mobile
SUR-FIT Natura Closed-End Pouch, Opaque, with 2-Sided Comfort Panel, 2 3/4 in
CONVATEC, PURCHASING DEPARTMENT
413172
Not in Commercial Distribution

  • 10768455106322 ()
  • 00768455106325 ()
  • 80768455106321 ()


  • One-piece intestinal ostomy bag, closed-ended
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