Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004142665

FEI Number

3004142665

Entity Name

ORASURE TECHNOLOGIES INC.

City/State/Country

BETHLEHEM, PA, US

Establishment Address

220 EAST FIRST STREET, BETHLEHEM, PA 18015, US

Establishment Type(s)

Manufacture 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

N/A

PMA Number

BP120001

All Registered Proprietary Names

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) OMNIgene-GUT (OMD-200) OraSure HIV-1 Oral Specimen Collection Device OraQuick ADVANCE Rapid HIV 1/2 ORAcollect Dx (OCD-100, OCD-100A) OraQuick Ebola Rapid Antigen Test InteliSwab COVID-19 Rapid Test Pro InteliSwab COVID-19 Rapid Test InteliSwab COVID-19 Rapid Test Rx OraQuick In-Home HIV test OraQuick HIV Self-Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
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
QID	Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens	Microbiology	Class 2	866.4002	2019-11-07
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-03-09
QSS	Hiv Self-Tests	Unknown	Class 3	N/A	2012-08-17

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
3003297763	ORASURE TECHNOLOGIES, INC.	Bethlehem, PA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004142665. Last updated year: 2026. Please use registration number 3004142665 when referencing this establishment in official correspondence.