Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005118020

FEI Number

3009391812

Entity Name

QIAGEN Manchester Ltd

City/State/Country

Manchester Lancashire, GB

Establishment Address

CityLabs 2.0, 200 Hathersage Road, Manchester Lancashire M13 0BH, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

QIAGEN Manchester Ltd (Owner Number: 10023024)

Owner / Operator Contact Address

Citylabs 2.0, 200 Hathersage Road, Manchester, GB-LAN M13 0BH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rotor-Gene Q MDx QIAsymphony RGQ MDx QIAstat-Dx® Analyzer 1 QIAstat-Dx® Analyzer 2 QIAcube EZ1 Advanced XL QIAsymphony SP

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	2017-12-15
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2017-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Hina Patel Business: QIAGEN Email: hina.patel@qiagen.com Phone: (240) 4773805

Related Public Records

Same Entity

QIAGEN Manchester Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005118020. Last updated year: 2026. Please use registration number 3005118020 when referencing this establishment in official correspondence.