DeviceEstablishmentPulse / report
Orasure Technologies, Inc. (manufacturer, Bethlehem, PA): 1 new FDA device listing, incl. reagents, ebola zaire virus (detected in the west africa outbreak in 2
Orasure Technologies, Inc. (Bethlehem, Pennsylvania): 1 new FDA device listing, incl. reagents, ebola zaire virus (detected in the west africa outbreak in 2. Its amount of 1 is above the median of 1 (50th percentile). Dated 83 days ago, it serves as a historical benchmark. Score 55/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 43 related PA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Orasure Technologies, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Bethlehem, PA, US |
| New listings | 1 |
| Devices | Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid |
| Product codes | POG |
| Device classes | Not classified |
| Brand names | OraQuick Ebola 2 Rapid Antigen Test |
| First new listing | 2026-08-13 |
| Latest new listing | 2026-08-13 |
| FDA registration number | 3003297763 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (44 PA 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: 2026-08-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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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: Orasure Technologies, Inc. and 44 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 44
- Orasure Technologies, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $8,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Orasure Technologies, Inc. in Bethlehem, Pennsylvania?
Orasure Technologies, Inc. (Bethlehem, PA), a manufacturer, added 1 FDA device listing on 2026-08-13.
How does Orasure Technologies, Inc. compare to other Pennsylvania DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 83 days old; check the official source for later updates before acting.
Orasure Technologies, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Orasure Technologies, Inc. | Bethlehem, PA | 1 | 50th | 2026-08-13 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
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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.