Abbott Diagnostics Scarborough, Inc.

FDA Device Registration & Listing · Portland, ME, US · Registration 3029059580

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029059580
FEI Number
3029059580
Entity Name
Abbott Diagnostics Scarborough, Inc.
City/State/Country
Portland, ME, US
Establishment Address
65 Gannett Dr, Portland, ME 04106, US
Establishment Type(s)
Repack or Relabel Medical Device,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
N
Expiration Date (Year)
2026
510(k) Number
K141520
PMA Number
N/A

All Registered Proprietary Names

ID NOW™ Instrument

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2014-06-27
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2014-06-27
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2014-06-27

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
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2025 Luminex Molecular Diagnostics Inc 2
NxTAG Respiratory Pathogen Panel, REF: I051C0447

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029059580. Last updated year: 2026. Please use registration number 3029059580 when referencing this establishment in official correspondence.
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