Abbott Diagnostics Scarborough, Inc.

FDA Device Registration & Listing · Westbrook, ME, US · Registration 3017662853

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
3017662853
FEI Number
3017662853
Entity Name
Abbott Diagnostics Scarborough, Inc.
City/State/Country
Westbrook, ME, US
Establishment Address
5 Bradley Dr, Westbrook, ME 04092, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
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
N/A
PMA Number
N/A

All Registered Proprietary Names

Alere BinaxNOW Legionlla Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Test BinaxNow Malaria Test Clearview PBP2a SA Culture Colony Test BinaxNOW Streptococcus pneumoniae Antigen Card BinaxNOW Streptococcus pneumoniae Test Alere BinaxNOW Streptococcus pneumoniae Antigen Card Alere Reader Alere BinaxNOW Influenza A & B Card 2 BinaxNOW Influenza A & B Card 2 DIGIVAL BinaxNow G6PD Test BinaxNOW RSV Test Alere BinaxNOW RSV Card BinaxNOW RSV Card BinaxNOW COVID-19 Antigen Self-Test (EUA210264) BinaxNOW COVID-19 Ag Card Home Test (EUA203107) BinaxNOW COVID-19 Ag Card (EUA202537) Panbio™ COVID-19 Antigen Self-Test (Abbott Diagnostics Korea Inc.) BinaxNOW COVID-19 Positive Control Swab Kit BinaxNOW COVID-19 Reagent Accessory Pack BinaxNOW Malaria Positive Control BinaxNOW Strep A Card Alere BinaxNOW Strep A Card BinaxNow Strep A Test Alere Determine HIV-1/2 Ag/Ab Combo Determine HIV-1/2 Ag/Ab Combo Determine HIV-1/2 Ag/Ab Combo Controls Alere Determine HIV-1/2 Ag/Ab Combo Controls BinaxNOW™ COVID-19 Ag Card BinaxNOW™ COVID-19 Antigen Self Test BinaxNOW Influenza A & B Card BinaxNOW Influenza A & B Control Swab Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2008-12-02
OAX Plasmodium Spp. Detection Reagents Microbiology Class 2 866.3402 2007-12-05
MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Microbiology Class 2 866.1640 2015-04-22
GTZ Antisera, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2007-12-05
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2017-08-01
JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening Hematology Class 2 864.7360 2008-12-02
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Microbiology Class 1 866.3480 2007-12-05
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2020-08-31
MJZ Kit, Direct Antigen, Positive Control Clinical Chemistry Class 1 862.1660 2010-01-08
GTZ Antisera, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2007-12-05
QSU Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test Microbiology Class 2 866.3956 2013-09-10
QYT Over-The-Counter Covid-19 Antigen Test Microbiology Class 2 866.3984 2025-02-27
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2010-01-08

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 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241317 Guangzhou Wondfo Biotech Co., Ltd. Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) 2024-09-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017662853. Last updated year: 2026. Please use registration number 3017662853 when referencing this establishment in official correspondence.
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