Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221359

FEI Number

1221359

Entity Name

Abbott Diagnostics Scarborough, Inc.

City/State/Country

Scarborough, ME, US

Establishment Address

10 Southgate Rd, Scarborough, ME 04074, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clearview PBP2a SA Culture Colony Test BinaxNOW COVID-19/Flu A&B Combo Self Test BinaxNOW COVID-19/Flu A&B ID NOW COVID-19 2 ID NOW COVID-19 2 Control Swab Kit ID NOW Molecular System Alere i Strep A 2 ID NOW Instrument Alere i Instrument ID NOW Strep A 2 WOUNDCHEK Bacterial Status Control Kit WOUNDCHEK Bacterial Status BinaxNow G6PD 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 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 Strep A Card Alere BinaxNOW Strep A Card BinaxNow Strep A Test Alere BinaxNOW Legionlla Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Card BinaxNOW Legionella Urinary Antigen Test BinaxNOW Streptococcus pneumoniae Antigen Card BinaxNOW Streptococcus pneumoniae Test Alere BinaxNOW Streptococcus pneumoniae Antigen Card Alere NMP22 BladderChek Control Kit Matritech NMP22 BladderChek Control Kit NMP22 BladderChek Control Kit Abbott Bulk Universal Collection Kit (List 09N92-010) Legionella Urinary Antigen Enzyme Immunoassay Kit ID NOW Molecular System ID NOW Instrument Alere i RSV ID NOW RSV Alere i Instrument BinaxNOW RSV Test Alere BinaxNOW RSV Card BinaxNOW RSV Card BinaxNow Malaria Test BinaxNOW Malaria Positive Control ID NOW Instrument NMP22 Urine Collection Kit Matritech NMP22 ELISA Test Kit Matritech NMP22 Bladdercheck Test NMP22 BladderChek Test NMP22 Test Alere NMP22 Test Kit Alere NMP22 BladderChek 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
MYI	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	Microbiology	Class 2	866.1640	2015-04-22
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-01-31
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	Microbiology	Class 2	866.3982	2023-08-11
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2018-05-10
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2018-05-10
QFA	Assay For Detection Of Proteases In Chronic Wounds	Microbiology	Class 2	866.3231	2020-01-10
JBF	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	Hematology	Class 2	864.7360	2008-12-02
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Microbiology	Class 2	866.3956	2013-09-10
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-08-31
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2007-12-05
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2008-12-02
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2007-12-05
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	Class 2	866.6010	2008-01-17
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-18
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2007-12-05
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2016-09-20
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-09-20
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-09-20
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2007-12-05
OAX	Plasmodium Spp. Detection Reagents	Microbiology	Class 2	866.3402	2007-12-05
JBE	Cell Enzymes (Erythrocytic And Leukocytic)	Hematology	Class 2	864.7100	2012-02-03
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
NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer	Unknown	Class 3	N/A	2008-01-17
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 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
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

Similar Registrations

Registration Number	Establishment Name	Location
3017662853	Abbott Diagnostics Scarborough, Inc.	Westbrook, ME, US
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
8020667	MAST GROUP LTD.	BOOTLE, MERSEYSIDE Liverpool, GB
3005174594	NANO-DITECH CORPORATION	Cranbury, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221359. Last updated year: 2026. Please use registration number 1221359 when referencing this establishment in official correspondence.