ORASURE TECHNOLOGIES, INC.

FDA Device Registration & Listing · Bethlehem, PA, US · Registration 3003297763

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003297763
FEI Number
3003297763
Entity Name
ORASURE TECHNOLOGIES, INC.
City/State/Country
Bethlehem, PA, US
Establishment Address
150 WEBSTER ST, Bethlehem, PA 18015, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ORASURE TECHNOLOGIES, INC. (Owner Number: 9000083)
Owner / Operator Contact Address
220 EAST FIRST STREET, --, Bethlehem, PA 18015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN190025
PMA Number
N/A

All Registered Proprietary Names

OraQuick ADVANCE Rapid HIV 1/2 OraSure HIV-1 Oral Specimen Collection Device OraQuick HCV Rapid Antibody Test OraQuick Ebola Rapid Antigen Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QSU Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test Microbiology Class 2 866.3956 2007-11-19
QSU Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test Microbiology Class 2 866.3956 2013-12-26
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2011-12-20
QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens Microbiology Class 2 866.4002 2019-11-07

Official Correspondent

Tiffany Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORASURE TECHNOLOGIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3022474803 ORASURE TECHNOLOGIES, INC. Bethlehem, PA, US
3004142665 ORASURE TECHNOLOGIES INC. BETHLEHEM, PA, US

Similar Registrations

Registration Number Establishment Name Location
3004142665 ORASURE TECHNOLOGIES INC. BETHLEHEM, PA, US
3012494290 SANICURE BV SCHIPHOL Noord-Holland, NL
3022474803 ORASURE TECHNOLOGIES, INC. Bethlehem, PA, US
1221359 Abbott Diagnostics Scarborough, Inc. Scarborough, ME, US
3017662853 Abbott Diagnostics Scarborough, Inc. Westbrook, ME, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003297763. Last updated year: 2026. Please use registration number 3003297763 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.