Are the swabs packaged and sterilized?

Test swab samples are available in sterilized or unsterilized options, based on customer needs.

What is the manufacturers capacity?

Up to 1 Million per day through our network of Envision One users.

Are the swabs FDA approved?

The swabs are Class 1 and do not require FDA approval but are registered on the FDA website.

An IRB-approved clinical trial was completed in April 2020.

Applicable FDA codes:

  • Applicator, Absorbent Tipped, Sterile, Product Code KXG
  • Applicator, Absorbent Tipped, Non-Sterile, Product Code KXF

Do the swabs cause any interference with PCR or molecular test platforms?

As part of the rigorous testing performed by BIDMC, a spiked sample was used to test performance of the 3D printed swab against a polyester control swab. The results between the two swabs did not vary.


  • Total Length: 148mm
  • Handle Diameter: 2.5mm
  • Neck Diameter: 1mm
  • Neck Length: 39mm
  • Head Diameter: 3mm
  • Head Length: 17mm
  • Head Feature Thickness: 0.4mm
  • Handle Breakpoint Diameter: 1.5mm


  • E-Guide Soft C-29C resin
  • Non-cytotoxic, not a sensitizer, non irritating