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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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This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX Analyzer
Spartan Bioscience Inc
01004777
In Commercial Distribution

  • 00628055420019 ()
01004777

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
VELA OPERATIONS SINGAPORE PTE. LTD.
300216
In Commercial Distribution

  • 08885013953664 ()
300216

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.
VELA OPERATIONS SINGAPORE PTE. LTD.
400125
In Commercial Distribution

  • 08885013950021 ()
400125

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
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