# Orasure Technologies Inc. (contract manufacturer, Bethlehem, PA): 1 new FDA device listing, incl. device for home collection and transport of specimens by lay users for

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Orasure Technologies Inc. |
| Owner / operator | Orasure Technologies, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Bethlehem, PA, US |
| New listings | 1 |
| Devices | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay |
| Product codes | SIH |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | Colli-Pee Dx Urine Collection Kit |
| First new listing | 2026-07-20 |
| Latest new listing | 2026-07-20 |
| FDA registration number | 3004142665 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.