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Orasure Technologies, Inc.: FDA-registered device maker in Bethlehem, PA, United States, 1 510(k) clearance and 1 PMA approval

Name: Orasure Technologies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Orasure Technologies, Inc. is registered with the FDA (registration 3003297763) in Bethlehem, PA, United States. It lists 6 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated October 10, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003297763
Address: 150 Webster ST, Bethlehem, PA, United States, 18015
Owner or operator: ORASURE TECHNOLOGIES, INC. (9000083)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 19, 2007
Registered through: 2027
Brand names listed: InteliSwab COVID-19 Rapid Test, InteliSwab COVID-19 Rapid Test Pro, InteliSwab COVID-19 Rapid Test Rx, OraQuick ADVANCE Rapid HIV 1/2, OraQuick Ebola 2 Rapid Antigen Test, OraQuick Ebola Rapid Antigen Test, OraQuick HCV Rapid Antibody Test, OraQuick HIV Self-Test and more

Devices it lists

Device	Product code	Class	Role	Source
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment, Specification developer	accessdata.fda.gov
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens	QID	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Hiv Self-Tests	QSS	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	QSU	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid	POG	N	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 10, 2019	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	Unknown	OraSure Technologies, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 25, 2010	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	35	April 20, 2021	accessdata.fda.gov

Compare with other makers

Updated April 20, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.