Nasopharyngeal Swabs for
Medical TI's COVID-19 initiative has converted our FDA-registered facility for the production of Nasopharyngeal (NP) Swabs for the detection of COVID-19. Our swabs utilize a design, material, and manufacturing process that is both preferred by leading healthcare providers¹ and registered with the FDA² for use in testing for COVID-19.
Our NP swabs can bend over 180° and do not snap or shatter.
Applicator, Absorbent Tipped, Sterile, Product Code KXG: Link
Applicator, Absorbent Tipped, Non-Sterile, Product Code KXF: Link
Won't Interfere with PCR/Reagents
In 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
We have reoriented our FDA-registered facility and equipment for the rapid production and shipment of NP swabs.
In testing, our swabs
continued to perform the same after being sterilized by steam at 270°F at 27 Pa in an autoclave.
Beth Israel Deaconess Medical Center (BIDMC), which ran the trial, received positive comments from study staff for comfort, flexibility, and ease of insertion, which we attribute to the use of EnvisionTEC’s E-Guide Soft material.
Total Length: 148mm
Neck Diameter: 1mm
Neck Length: 39mm
Handle Diameter: 2.5mm
Handle Breakpoint Diameter: 1.5mm
Head Feature Thickness: 0.4mm
Head Diameter: 3mm
Head Length: 17mm
Material: E-Guide Soft C-29C Resin (Non-cytotoxic, not a sensitizer, non irritating.)
April 20, 2020 – BIDMC-led clinical trial identifies four novel 3D-printed swabs for use in COVID-19 testing – Link
April 15, 2020 – EnvisionTEC to 3D Print Mass Quantities of Nasopharyngeal Swabs for COVID-19 Testing Based on Successful Clinical Trial – Link
March 29, 2020 – EnvisionTEC Partners With Healthcare Community to Battle Global Pandemic – Link
Preprint of BIDMC manuscript: Link
EnvisionTEC 3D Printed Swabs Description, FAQ, and Specifications: Link
Medical TI Nasopharyngeal (NP) Swab Regulatory Information:
NP Swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR 880.6025 Absorbent tipped applicator.
Medical TI's NP Swabs have been developed by EnvisionTEC, Inc. with review from Beth Israel Deaconess Medical Center (BIDMC). Our swab designs have unique FDA Device Listing Numbers: D396115 (Sterile) and D397217 (Non-Sterile).