Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014553740

FEI Number

3014553740

Entity Name

STAT-Dx Life, S.L.

City/State/Country

Barcelona, ES

Establishment Address

Baldiri Reixac 4, Barcelona 08028, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

QIAGEN, GmbH (Owner Number: 9065957)

Owner / Operator Contact Address

QIAGEN STRASSE 1, --, HILDEN, DE-NOTA 40724, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QIAstat-Dx Respiratory SARS-CoV-2 Panel QIAstat-Dx Respiratory Panel Plus QIAstat-Dx Respiratory Panel Mini QIAstat-Dx Meningitis-Encephalitis (ME) Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-04-01
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-06-11
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	Microbiology	Class 2	866.3970	2025-01-21

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, GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004013603	QIAGEN, GMBH	HILDEN North Rhine-Westphalia, DE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014553740. Last updated year: 2026. Please use registration number 3014553740 when referencing this establishment in official correspondence.