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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CLIA Waived Methamphetamine Test Panel (MET)
Medical Disposables Corp
M-DMA-114
In Commercial Distribution

  • 00850969007912 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Cocaine Test Panel (COC)
Medical Disposables Corp
M-DCO-114
In Commercial Distribution

  • 00850969007905 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Benzodiazepine Test Panel (BZO)
Medical Disposables Corp
M-DBZ-114
In Commercial Distribution

  • 00850969007653 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Buprenorphine Test Panel (BUP)
Medical Disposables Corp
M-DBU-114
In Commercial Distribution

  • 00850969007639 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Amphetamine Test Panel (AMP)
Medical Disposables Corp
M-DAM-114
In Commercial Distribution

  • 00850969007622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Methadone Test Panel (MTD)
Medical Disposables Corp
M-DMT-114
In Commercial Distribution

  • 00850969007615 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Benzodiazepine Test Panel (BZO)
Medical Disposables Corp
M-DBZ-114
In Commercial Distribution

  • 00850969007592 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Buprenorphine Test Panel (BUP)
Medical Disposables Corp
M-DBU-114
In Commercial Distribution

  • 00850969007585 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ab Binder, Extra Large (4 Panel)
PEPPER MEDICAL INC.
AB475
In Commercial Distribution

  • 00850014574598 ()
AB475

  • Abdominal binder, single-use
Rapid Response Multi Drug Test Panel
BTNX Inc
D6.47-1P29-25
In Commercial Distribution

  • 00722066004814 ()
  • 00722066004821 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel One Step DOA Cup
BTNX Inc
D7.3-1V
In Commercial Distribution

  • 00722066004630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Rapid Multi-Drug Test Cup
MAXPERT MEDICAL
CDTC121
Not in Commercial Distribution

  • 10852359007066 ()
  • 00852359007069 ()
  • 20852359007063 ()
CDTC121

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution

  • M70883113970 ()
  • M70885113983 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Kit BD MAX Enteric Viral Panel
BECTON, DICKINSON AND COMPANY
443985
In Commercial Distribution

  • 00382904439859 ()
443985

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
442963
In Commercial Distribution

  • 00382904429638 ()
442963

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Parasite Panel
BECTON, DICKINSON AND COMPANY
442960
In Commercial Distribution

  • 00382904429607 ()
442960

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
KIT, DOOR PANEL w' QUIKCLOT - BLK
NORTH AMERICAN RESCUE, LLC
80-1167
In Commercial Distribution

  • 00842209119004 ()
80-1167

  • First aid kit, medicated
KIT, TORK w' DETACH PANEL - BLK
NORTH AMERICAN RESCUE, LLC
85-1946
In Commercial Distribution

  • 00842209106899 ()
85-1946

  • First aid kit, non-medicated, single-use
BIPOLAR SOCKET, NEW STYLE PANEL MOUNTED
ELMED INCORPORATED
5-001
In Commercial Distribution

  • 00198506074097 ()
5-001

  • Electrosurgical cable adaptor
HYDRATHERM CONTROL PANEL SCREW REPAIR PART
COMPASS HEALTH BRANDS CORP.
HT-TU-CNTRLPNLS
In Commercial Distribution

  • 00092237626009 ()


  • Hot therapy pack heating unit
5 Panel with BZO, 300ng OPI
AMERICAN BIO MEDICA CORPORATION
10-5Z1-030
In Commercial Distribution

  • 10694644300458 ()
  • 10694644350453 ()
10-5Z1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 PANEL W/METH,OXY, OPI300
AMERICAN BIO MEDICA CORPORATION
10-5MO1-030
In Commercial Distribution

  • 10694644300281 ()
  • 10694644350286 ()
10-5MO1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Coc & Meth Single
AMERICAN BIO MEDICA CORPORATION
10-2CM1-000
In Commercial Distribution

  • 10694644300083 ()
  • 10694644350088 ()
10-2CM1-000

  • Oxycodone IVD, calibrator
10 panel RAPIDTOX CUP II: AMP
AMERICAN BIO MEDICA CORPORATION
10-10XX2AB-030
In Commercial Distribution

  • 10694644200369 ()
  • 10694644250364 ()
10-10XX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
8 panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-8XT-030
In Commercial Distribution

  • 10694644100225 ()
  • 10694644150220 ()
10-8XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 2000
AMERICAN BIO MEDICA CORPORATION
10-10XT-200
In Commercial Distribution

  • 10694644100041 ()
  • 10694644150046 ()
10-10XT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-10XT-030
In Commercial Distribution

  • 10694644100034 ()
  • 10694644150039 ()
10-10XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel InCup w/THC & Meth
AMERICAN BIO MEDICA CORPORATION
10-2MC-000
In Commercial Distribution

  • 10694644400141 ()
  • 10694644450146 ()
10-2MC-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS
AMD Medicom Inc
2213
In Commercial Distribution

  • 20686864048026 ()
  • 10686864048029 ()
  • 00686864048022 ()
2213

  • Surgical sponge-counting tray
Custom UTAK QC Negative Fentanyl Panel
UTAK LABORATORIES, INC.
FENT + NEG U KP
In Commercial Distribution

  • B800FENTNEGUKP5 ()
  • B800FENTNEGUKP0 ()

  • Total Volume: 1 Milliliter
FENT + NEG U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
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