Data / Medical devices / United States / Abbott Diagnostics Scarborough, Inc.

Abbott Diagnostics Scarborough, Inc.: FDA-registered device maker in Scarborough, ME, United States, 18 510(k) clearances and 1 PMA approval

Name: Abbott Diagnostics Scarborough, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Diagnostics Scarborough, Inc. is registered with the FDA (registration 1221359) in Scarborough, ME, United States. It lists 24 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated January 13, 2025. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1221359
Address: 10 Southgate Rd, Scarborough, ME, United States, 04074
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: July 19, 1996
Registered through: 2026
Brand names listed: Abbott Bulk Universal Collection Kit (List 09N92-010), Alere BinaxNOW Influenza A & B Card 2, Alere BinaxNOW Legionlla Urinary Antigen Card, Alere BinaxNOW RSV Card, Alere BinaxNOW Strep A Card, Alere BinaxNOW Streptococcus pneumoniae Antigen Card, Alere Determine HIV-1/2 Ag/Ab Combo, Alere Determine HIV-1/2 Ag/Ab Combo Controls and more

Devices it lists

Device	Product code	Class	Role	Source
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Manufacturer	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Manufacturer	accessdata.fda.gov
Assay For Detection Of Proteases In Chronic Wounds	QFA	2	Manufacturer	accessdata.fda.gov
Cell Enzymes (Erythrocytic And Leukocytic)	JBE	2	Manufacturer for export	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, General Purpose, Microbiology, Diagnostic	LIB	1	Manufacturer for export	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Specification developer	accessdata.fda.gov
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	JBF	2	Manufacturer	accessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	PGX	2	Manufacturer, Specification developer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Manufacturer, Specification developer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Manufacturer, Specification developer	accessdata.fda.gov
Kit, Direct Antigen, Positive Control	MJZ	1	Manufacturer	accessdata.fda.gov
Legionella, Spp., Elisa	MJH	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	2	Repackager or relabeler	accessdata.fda.gov
Plasmodium Spp. Detection Reagents	OAX	2	Manufacturer	accessdata.fda.gov
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	QSU	2	Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer, Specification developer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer, Specification developer	accessdata.fda.gov
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	QWR	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	MYI	2	Manufacturer	accessdata.fda.gov
System, Test, Tumor Marker, For Detection Of Bladder Cancer	NAH	3	Manufacturer	accessdata.fda.gov
System, Test, Tumor Marker, Monitoring, Bladder	MMW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 13, 2025	K243262	QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test	SCA	Substantially Equivalent	Osang, LLC	accessdata.fda.gov
August 10, 2023	K221925	ID NOW COVID-19 2.0	QWR	Substantially Equivalent	Abbott Diagnostics Scarborough, Inc.	accessdata.fda.gov
December 2, 2019	DEN180014	WOUNDCHEK Bacterial Status	QFA	Unknown	Alere Scarborough, Inc.	accessdata.fda.gov
May 2, 2018	K173653	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit	PGX	Substantially Equivalent	Alere Scarborough, Inc.	accessdata.fda.gov
September 29, 2017	K171792	Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit	OCC	Substantially Equivalent	Alere Scarborough, Inc.	accessdata.fda.gov
April 10, 2017	K162642	Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	PSZ	Substantially Equivalent	Alere Scarborough, Inc.	accessdata.fda.gov
August 18, 2016	K161375	Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit	OCC	Substantially Equivalent	Alere Scarborough, Inc.	accessdata.fda.gov
September 3, 2014	K133851	ALERE PBP2A SA/CONS CULTURE COLONY TEST	MYI	Substantially Equivalent	Alere Scarborough, Inc.	accessdata.fda.gov
June 13, 2014	K141520	ALERE I INFLUENZA A & B	OCC	Substantially Equivalent	Alere Scarborough, Inc D/B/A Binax, Inc.	accessdata.fda.gov
September 1, 2009	K083744	BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010	MJZ	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov
October 23, 2008	K080003	BINAXNOW G6PD TEST	JBF	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov
June 13, 2007	DEN070006	BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX	OAX	Unknown	Inverness Medical Professional Diagnostics-Binax	accessdata.fda.gov
March 15, 2007	K070522	MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012	MJH	Substantially Equivalent	Inverness Medical Professional Diagnostics	accessdata.fda.gov
October 21, 2003	K032166	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065	GQG	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov
July 30, 2002	K021231	NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT	MMW	Substantially Equivalent	Matritech, Inc.	accessdata.fda.gov
November 30, 2001	K012521	BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST	GTZ	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov
March 22, 1996	K960712	BINAX STREP A TEST	GTZ	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov
September 20, 1994	K934965	BINAX LEGIONELLA URINARY ANTIGEN EIA	MJH	Substantially Equivalent	Binax, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 2, 1996	P940035	NMP22 BladderChek Test	NAH	17	July 12, 2022	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 9, 2026	98400	Class II	Ongoing	Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable	It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.	accessdata.fda.gov
March 4, 2025	96519	Class II	Ongoing	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: N	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.	accessdata.fda.gov
March 4, 2025	96500	Class II	Ongoing	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: N	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.	accessdata.fda.gov
June 26, 2015	71585	Class II	Terminated	Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid a	Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit	accessdata.fda.gov
April 22, 2015	71059	Class II	Terminated	Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology	High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.	accessdata.fda.gov
April 6, 2009	51871	Not yet classified	Terminated	Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.	Potential for false positive Strep A results.	accessdata.fda.gov
March 28, 2007	37843	Not yet classified	Terminated	BinaxNOW Influenza A&B 10 Test KIT Part Number: contains NP Swabs with '8995' labeled on the swab wrapper	Tip of the foam swab could detach from the shaft causing injury to the patient.	accessdata.fda.gov
September 29, 2006	36699	Not yet classified	Terminated	NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code:	Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches	accessdata.fda.gov
February 18, 2004	28457	Not yet classified	Terminated	NOW RSV Test Item Number, Kit Number 430-00R	Pouch integrity compromised	accessdata.fda.gov

Compare with other makers

Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.