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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Pocguide Multi-Drug Test Panel (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802646 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
CareRay Digital Medical Technology Co., Ltd.
EverestView 4343X
In Commercial Distribution

  • 06970597830752 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Le
In Commercial Distribution

  • 06970597830721 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 4343W
In Commercial Distribution

  • 06970597832022 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 3643W
In Commercial Distribution

  • 06970597831049 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cwe
In Commercial Distribution

  • 06970597830745 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 3600RF
In Commercial Distribution

  • 06970597830479 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750Cw
In Commercial Distribution

  • 06970597830363 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750C
In Commercial Distribution

  • 06970597830349 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800RF
In Commercial Distribution

  • 06970597830271 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800L
In Commercial Distribution

  • 06970597830240 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800R
In Commercial Distribution

  • 06970597830219 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cwe
In Commercial Distribution

  • 06970597830172 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cw
In Commercial Distribution

  • 06970597830097 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500L
In Commercial Distribution

  • 06970597830073 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500C
In Commercial Distribution

  • 06970597830066 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500P
In Commercial Distribution

  • 06970597830035 ()


  • Portable basic diagnostic x-ray system, digital
AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804830212 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 Strips, including MOR300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802608 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801656 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801397 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712228
In Commercial Distribution

  • 00884838085695 ()
712228

  • Stationary basic diagnostic x-ray system, digital
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712227
In Commercial Distribution

  • 00884838085688 ()
712227

  • Stationary basic diagnostic x-ray system, digital
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712226
In Commercial Distribution

  • 00884838085671 ()
712226

  • Stationary basic diagnostic x-ray system, digital
PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)
IDUN SOLUTIONS LLC
IDOA-3105
Not in Commercial Distribution

  • 00857275007261 ()
  • 00857275007186 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific 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
eSensor® Respiratory Viral Panel Reagent (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005139 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Amplification Reagents (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005115 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
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