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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HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.02 standard version
In Commercial Distribution

  • 08033928530184 ()


  • Blood donation rocker
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.01 RFID version
In Commercial Distribution

  • 08033928530177 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX3.WIFI.RFID
In Commercial Distribution

  • 08033928530061 ()


  • Blood donation rocker
BD MAX Check-Points CPO contains: 24 each, Master Mix, Reagent Strips, Extraction Tubes, Sample Buffer Tubes, Septum Caps. The BD MAX Check-Points CPO Assay detects the presence of carbapenemase genes in Gram-negative bacteria and includes an internal Sample Processing Control.
Check-Points Health B.V.
278102
In Commercial Distribution

  • 00180002781029 ()
278102

  • Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)
Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT Cartridge Kit
Not in Commercial Distribution

  • 04260364750034 ()
10049

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Basic version))
DELCON SRL
HMIX3.485
In Commercial Distribution

  • 08033928530016 ()


  • Blood donation rocker
A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 01812125010036 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD
Product Name : Start Kit This original PEAKOSIL Start Kit(NSSK) is a kit including PEAKOSIL Light Body 2 EA, PEAKOSIL Putty 1 EA, Yellow Mix Tip 6 EA & Intra Oral Tip 6 EA. The contents of this kit are all registered in FDA.
NEOSIL Co., Ltd
NSSK
In Commercial Distribution

  • 18800026400070 ()
  • 08800026400073 ()


  • Dental impression material kit, single-use
Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT BAL Cartridge Kit
Not in Commercial Distribution

  • 04260364750058 ()
10091

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
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