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
Orasure Technologies Inc. (Bethlehem, Pennsylvania): 1 new FDA device listing, incl. device for home collection and transport of specimens by lay users for. Its amount of 1 is above the median of 1 (50th percentile). Dated 107 days ago, it serves as a historical benchmark. Score 65/100. 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 15 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. |
| 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 |
| 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: 2026-07-20
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (PA first): Philips Ultrasound LLC (contract manufacturer, Reedsville, P · Arch Medical Solutions - Philadelphia, LLC Dba Jade Precisio · Globus Medical, Inc. (manufacturer, Audubon, PA) · Alta Smiles, LLC (manufacturer, Fort Washington, PA) · Synthes (USA) Products LLC (specification developer, West Ch · 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: 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)
65 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Orasure Technologies Inc. in Bethlehem, Pennsylvania?
Orasure Technologies Inc. (Bethlehem, PA), a contract manufacturer, added 1 FDA device listing on 2026-07-20.
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 107 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 | 2026-07-20 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
Related records
DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Pennsylvania
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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.