Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022474803

FEI Number

3022474803

Entity Name

ORASURE TECHNOLOGIES, INC.

City/State/Country

Bethlehem, PA, US

Establishment Address

2685 Opus Way, --, Bethlehem, PA 18020, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ORASURE TECHNOLOGIES, INC. (Owner Number: 9000083)

Owner / Operator Contact Address

220 EAST FIRST STREET, --, Bethlehem, PA 18015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200040

PMA Number

N/A

All Registered Proprietary Names

OraQuick HCV Rapid Antibody Test OraQuick In-Home HIV test OraQuick HIV Self-Test OraQuick Ebola Rapid Antigen Test Oragene Dx (OGD-500, OGD-575) OraSure HIV-1 Oral Specimen Collection Device OraQuick ADVANCE Rapid HIV 1/2 ORAcollect DNA (ORE-100) ORAcollect DNA (OCR-100) Oragene DNA (OG-250, OG-500, OG-510, OG-575, OG-600, OG-610, OG-675) Oragene ONE (ON-500, ON-600) Oragene Dx (OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675) ORAcollect RNA (OR-10; ORE-100) OMNIgene ORAL (OM-505, OME-505) ORAcollect Dx (OCD-100, OCD-100A) OMNIgene-GUT (OMD-200)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2011-12-20
QSS	Hiv Self-Tests	Unknown	Class 3	N/A	2012-08-17
QID	Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens	Microbiology	Class 2	866.4002	2019-11-07
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2021-02-24
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Microbiology	Class 2	866.3956	2013-12-26
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Microbiology	Class 2	866.3956	2007-11-19
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2021-02-24
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2021-02-24
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2020-12-11
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2021-02-24
QPO	Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples	Microbiology	Class 2	866.2952	2022-04-07

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
3003297763	ORASURE TECHNOLOGIES, INC.	Bethlehem, PA, US
3004142665	ORASURE TECHNOLOGIES INC.	BETHLEHEM, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

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3003297763	ORASURE TECHNOLOGIES, INC.	Bethlehem, PA, US
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022474803. Last updated year: 2026. Please use registration number 3022474803 when referencing this establishment in official correspondence.