# Assure Tech LLC (specification developer, Wilmington, DE): 2 new FDA device listings, incl. over-the-counter covid-19 antigen test

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Assure Tech LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Wilmington, DE, US |
| New listings | 2 |
| Devices | Over-The-Counter Covid-19 Antigen Test; Sperm, Antigen, Antiserum, Control |
| Product codes | QYT, DFQ |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology, Immunology |
| Brand names | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test; Home Sperm Test for Male Fertility |
| First new listing | 2026-06-10 |
| Latest new listing | 2026-07-24 |
| FDA registration number | 3030648160 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.