SWAB INFORMATION

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Design Parameters

  • Design Parameters: head, neck shaft and breakpoint
  • Length: 175 mm
  • Break point at: 
  • Swab diameter: 2.5 mm 
  • Flexible: only NP swab that can be bent 180 degrees
  • Only Swab that can be steam sterilized at the standard 270 degrees F without material degradation in mechanical properties









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Clinical Testing

"Analytical results were positive, with a high level of concordance with the reference swab and with subjective results showing that the swab performed neutrally, better than the other test swabs."

- Dr. Ray Arnaout, MD (Beth Israel Deaconess Medical Center


  • Validation; PCR, Mechanical testing, Sterilization: Passed all validation testing
  • 100 patient clinical study at Harvard BIDMC (IRB)
  • Collection Sufficiency: tested against Copan, model: 501CS01 (control swab) 
  • PCR Compatibility: tested on Abbott RealTime SARS-CoV-2 Assay on an Abbott m2000 RealTime System

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Manufacturing

  • FDA Approved, Class I device. Product Code KXG
  • Finished in ISO 13485 facility
  • Manufactured under 21 CFR 820
  • Batch manufacturing of 400 swabs
  • Printer Serial number
  • Material Lot number
  • Date
  • Batch #