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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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revogene™ - 00628055344001

The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
GenePoc Inc
130840
In Commercial Distribution

  • 00628055344001 ()
130840

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Software v3.1.1 Update Key for cobas Liat Analyzer - 07613336156926

No Description
Roche Molecular Systems, Inc.
08415129001
Not in Commercial Distribution

  • 07613336156926 ()
08415129001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Advanced Tools Key - 07613336119570

No Description
Roche Molecular Systems, Inc.
07886985001
In Commercial Distribution

  • 07613336119570 ()
07886985001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Analyzer - 07613336100097

No Description
Roche Molecular Systems, Inc.
07341920190
Not in Commercial Distribution

  • 07613336100097 ()
07341920190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Curaplex - 00812277036237

*THS ONLY* Heated Bi-PAP Setup Kit
BOUND TREE MEDICAL, LLC
670186-KIT
In Commercial Distribution

  • 00812277036237 ()
  • 00810094571245 ()
670186-KIT

  • Heated respiratory humidifier

cobas Liat Software Version 3.0 - 07613336119563

No Description
Roche Molecular Systems, Inc.
07886977001
Not in Commercial Distribution

  • 07613336119563 ()
07886977001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Analyzer Software 3.2 - 07613336148259

No Description
Roche Molecular Systems, Inc.
08276412001
In Commercial Distribution

  • 07613336148259 ()
08276412001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat System Software v3.1 Update Key for cobas Liat Analyzer - 07613336142738

No Description
Roche Molecular Systems, Inc.
08153248001
Not in Commercial Distribution

  • 07613336142738 ()
08153248001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Portex - 10351688414458

No Description
ICU MEDICAL, INC.
225-3717-800
In Commercial Distribution

  • 30351688414452 ()
  • 10351688414458 ()


  • Ventilator breathing circuit, single-use

Portex - 10351688413215

No Description
ICU MEDICAL, INC.
008015
Not in Commercial Distribution

  • 10351688413215 ()
  • 30351688413219 ()


  • Ventilator breathing circuit, single-use
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