Assure Tech LLC (specification developer, Wilmington, DE): 2 new FDA device listings, incl. over-the-counter covid-19 antigen test
Assure Tech LLC (Wilmington, Delaware): 2 new FDA device listings, incl. over-the-counter covid-19 antigen test. Its amount of 2 is above the median of 1 (69th percentile). Dated 103 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 36 related DE DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (37 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-24
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (DE first): Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Karl Storz Se & Co Kg (specification developer, TUTTLINGEN B · Medi.Plan GmbH & Co. Kg (foreign exporter, Dortmund North Rh · Rhenus Se & Co. Kg (foreign exporter, Holzwickede North Rhin · Karl Storz Se & Co. Kg (contract manufacturer, TUTTLINGEN Ba · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Assure Tech LLC and 37 Delaware peers
- Delaware DeviceEstablishmentPulse records like this one: 37
- Assure Tech LLC's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 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.
What is the DeviceEstablishmentPulse record for Assure Tech LLC in Wilmington, Delaware?
Assure Tech LLC (Wilmington, DE), a specification developer (outsources manufacturing), added 2 FDA device listings between 2026-06-10 and 2026-07-24.
How does Assure Tech LLC compare to other Delaware DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 103 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Assure Tech LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Assure Tech LLC | Wilmington, DE | 2 | 69th | 2026-07-24 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Delaware
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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.