Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007719797

FEI Number

3007719797

Entity Name

Instrumentation Laboratory SpA

City/State/Country

Ascoli Piceno Marche, IT

Establishment Address

Zona Industriale Campolungo 327a, 11, Ascoli Piceno Marche 63100, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Instrumentation Laboratory SpA (Owner Number: 10082968)

Owner / Operator Contact Address

Viale Monza 338, Milan, IT-25 20128, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aptiva System Rinse Aptiva System Cleaning Solution kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-10-18

Official Correspondent

Natale Bova

US Agent Details

Carol Marble Email: cmarble@werfen.com Phone: (800) 9559525

Related Public Records

Same Entity

Instrumentation Laboratory SpA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012348571	INSTRUMENTATION LABORATORY SPA	Roncello Lombardy, IT

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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3002773840	BioFire Diagnostics, LLC	Salt Lake City, UT, US
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE
2243471	ROCHE MOLECULAR SYSTEMS, INC.	Branchburg, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007719797. Last updated year: 2026. Please use registration number 3007719797 when referencing this establishment in official correspondence.