Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012449645

FEI Number

3012449645

Entity Name

DiaSorin Canada Inc.

City/State/Country

Mississauga Ontario, CA

Establishment Address

5075 Whittle Road, Suite 210 & 140, Mississauga Ontario L4Z 3N1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DiaSorin Inc. (Owner Number: 9051149)

Owner / Operator Contact Address

1951 Northwestern Ave, Stillwater, MN 55082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102314

PMA Number

N/A

All Registered Proprietary Names

LIAISON MDX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-03-31

Official Correspondent

Mari Meyer

US Agent Details

Mari Meyer Business: DiaSorin Inc. Email: Mari.Meyer@diasorin.com Phone: (651) 4399710

Related Public Records

Same Entity

DiaSorin 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
3008576040	DiaSorin Italia S.p.A UK Branch	Dartford Kent, GB
3004434309	DiaSorin Deutschland GmbH	Dietzenbach Hesse, DE
9610240	DiaSorin Italia S.p.A.	SALUGGIA Vercelli, IT
2182595	DIASORIN INC.	Stillwater, MN, US

Similar Registrations

Registration Number	Establishment Name	Location
3026886124	ROCGENE(XUZHOU) TECHNOLOGY LIMITED	Xuzhou Jiangsu, CN
1524213	MERIDIAN BIOSCIENCE, INC.	Cincinnati, OH, US
3004530258	CEPHEID	Sunnyvale, CA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012449645. Last updated year: 2026. Please use registration number 3012449645 when referencing this establishment in official correspondence.