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