Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1628664

FEI Number

1628664

Entity Name

ABBOTT LABORATORIES

City/State/Country

IRVING, TX, US

Establishment Address

1921 Hurd Dr, IRVING, TX 75038, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alinity s System Accessories Alinity s System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2016-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR
3038966633	Abbott Medical Mexico, S. de R.L. de C.V.	Santa Rosa Jauregui Queretaro, MX

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0011-2018	Abbott Laboratories, Inc	1	ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
Z-0016-05	Abbott Laboratories, Inc	1	AEROSET Analyzer, Systems Operation Manual.
Z-0020-2014	Abbott Laboratories, Inc	1	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.

Similar Registrations

Registration Number	Establishment Name	Location
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
3006198300	Diamond Diagnostics Inc.	Budapest, HU
1415939	ABBOTT LABORATORIES	Abbott Park, IL, US
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1628664. Last updated year: 2026. Please use registration number 1628664 when referencing this establishment in official correspondence.