Contract manufacturerORASURE TECHNOLOGIES INC. (Bethlehem, PA)PennsylvaniaClinical chemistryMicrobiologyClass II
ORASURE TECHNOLOGIES INC.
Contract manufacturer · Bethlehem, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004142665 (openFDA record; or search FDA's registration database)
- FEI number
- 3004142665
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- ORASURE TECHNOLOGIES, INC. (FDA owner/operator no. 9000083)
- Registered address
- 220 EAST FIRST STREET, Bethlehem, PA 18015
- Contract listings
- 4 device listings, 3 product codes, first listed Feb 24, 2021
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| OYJ | Dna Specimen Collection, Saliva | Class II | Clinical chemistry | Contract manufacturing | Feb 24, 2021 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | Class II | Microbiology | Contract manufacturing | Apr 7, 2022 |
| SIH | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | Class II | Microbiology | Contract manufacturing | Jul 20, 2026 |