# Orasure Technologies, Inc. (manufacturer, Bethlehem, PA): 1 new FDA device listing, incl. reagents, ebola zaire virus (detected in the west africa outbreak in 2

**Score:** 55/100

| 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 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.