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OraSure Technologies Inc.

USA · Bethlehem PA · www.orasure.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000009941

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

25UDI-DI device records

IVD A 3ivd-annex-ii-list-a 22

USUnited StatesFDA openFDA

12listed device types

Class I 1Class II 6Class III 1unclassified 4

plus 33 registration records and 30 510(k), 36 PMA

UKUnited KingdomMHRA PARD

4registered device records

IVD general 1IVD Annex II List A 3

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class II 14Class III 1

18 including historic records

TWTaiwanTFDA

1valid device licences

Class III 1

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 1 1

HKHong KongMDACS

1valid listings

IVD D 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union25 raw hits, 0 excluded, 25 confirmed

United States33 registration records, 30 510(k), 36 PMA

United Kingdom4 confirmed, 0 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: ORASURE TECHNOLOGIES, INC. · ORASURE TECHNOLOGIES INC. · ORASURE TECHNOLOGIES INC

Regulatory identity

EU manufacturer SRN: US-MF-000009941
EU authorised representative: QbD RepS BV
UK responsible person: Qarad UK Ltd.

Business registration

Legal name: ORASURE TECHNOLOGIES INC
CIK: 0001116463
Registration status: Active
Listing status: Listed (OSUR)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11996

21997

131998

11999

62000

22001

22002

12003

12006

12019

FDA listed device types

showing 8 of 12

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus 1Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay 1Dna Specimen Collection, Saliva 1Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens 1Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test 1Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples 1Research Use Only/Clinical Chemistry Devices 1Coronavirus Antigen Detection Test System. 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	10608337001065	OraQuick HIV Self-Test	ivd-annex-ii-list-a
EU	D-1001-0371C2	OraQuick HCV Rapid Antibody Test	ivd-annex-ii-list-a
EU	D-1001-0370BY	OraQuick HCV Rapid Antibody Test	ivd-annex-ii-list-a
EU	00608337001068	OraQuick HIV Self-Test	ivd-annex-ii-list-a
UK	48384	OraQuick HCV Rapid Antibody Test Kit Controls	IVD Annex II List A
UK	30829	OraQuick HCV Rapid Antibody Test	IVD Annex II List A
UK	65848	OraQuick HIV Self-Test	IVD Annex II List A
US	DEN190025	OraQuick Ebola Rapid Antigen Test	2019-10-10
US	K060859	COMPOUND W FREEZE OFF WART REMOVAL SYSTEM	2006-07-18
US	K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	2003-03-20
CA	912	Q.E.D. SALIVA ALCOHOL TEST	Class III
CA	19226	OPIATES MICRO-PLATE EIA	Class II
CA	19227	COCAINE METABOLITE MICRO-PLATE EIA	Class II