Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027273565

FEI Number

3027273565

Entity Name

Fujirebio Diagnostics AB

City/State/Country

Molndal Vastra Gotaland, SE

Establishment Address

Gemenskapens gata 7, Molndal Vastra Gotaland SE-431 53, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fujirebio Diagnostics, Inc. (Owner Number: 10022860)

Owner / Operator Contact Address

201 Great Valley Parkway, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Canag NSE EIA Kit AMH Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2012-01-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-03-05

Official Correspondent

Greg Dickson

US Agent Details

Greg Dickson Business: FUJIREBIO DIAGNOSTICS, INC. Email: dicksong@fdi.com Phone: (610) 2403888

Related Public Records

Same Entity

Fujirebio Diagnostics, 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
3000125561	Fujirebio Diagnostics, AB	Gothenburg Vastra Gotaland, SE
9615837	Fujirebio Europe N.V.	GHENT Oost-Vlaanderen, BE
3014643041	Fujirebio Inc. Ube Facility	Yamaguchi, JP
1643621	Fujirebio Diagnostics, Inc.	Seguin, TX, US
3002895169	Fujirebio Inc.	Sagamihara-shi Kanagawa, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

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9610240	DiaSorin Italia S.p.A.	SALUGGIA Vercelli, IT
2182595	DIASORIN INC.	Stillwater, MN, US
9710337	IBL INTERNATIONAL GMBH	HAMBURG, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027273565. Last updated year: 2026. Please use registration number 3027273565 when referencing this establishment in official correspondence.