📢 Corporate History & Recent Developments:
Abbott Diagnostics Scarborough, Inc. was originally part of Alere Inc., which was acquired by Abbott Laboratories in October 2017 for approximately $5.3 billion. In August 2020, Abbott purchased the 111,590-square-foot manufacturing facility at 10 Southgate Road, Scarborough, Maine for $16.95 million to expand domestic production of Rapid COVID-19 tests. The facility serves as a critical manufacturing hub for Abbott's Rapid Diagnostics business, producing FDA-cleared and EUA-authorized tests including the Determine HIV-1/2 Ag/Ab Combo, BinaxNOW COVID-19 antigen tests, and ID NOW molecular diagnostics.
Company Overview (Updated April 2026)
Abbott Diagnostics Scarborough, Inc. is a US-based medical device manufacturer and a wholly-owned subsidiary of Abbott Laboratories (NYSE: ABT), a global healthcare leader. Located in Scarborough, Maine, the company operates as part of Abbott's Rapid Diagnostics business unit, specializing in the development and production of point-of-care diagnostic tests for infectious diseases.
The facility's origins trace back to Alere Inc., a leADINg global manufacturer of rapid diagnostic products. Following Abbott's acquisition of Alere in October 2017, the Scarborough facility was integrated into Abbott's Diagnostics division. The site has played a critical role in the COVID-19 pandemic response, manufacturing the BinaxNOW COVID-19 Ag Card and ID NOW COVID-19 tests that received FDA Emergency Use Authorization in 2020.
Corporate Structure & History
- Legal Name: Abbott Diagnostics Scarborough, Inc.
- Parent Company: Abbott Laboratories (NYSE: ABT) - Global healthcare company with 114,000+ employees serving 160+ countries
- Former Parent: Alere Inc. (acquired by Abbott in October 2017 for ~$5.3 billion)
- Original Incorporation: March 14, 2005 (Delaware)
- New York Registration: June 3, 2020 (Document Number 5760818) - Foreign Business Corporation
- Jurisdiction: Delaware, United States
- Next Statement Due: June 30, 2026
- Registered Agent: C T Corporation System, 28 Liberty Street, New York, NY 10005
- Corporate Family: Part of Abbott corporate group comprising 448+ affiliated companies
Headquarters & Manufacturing Facility
Primary Address:
10 Southgate Road
Scarborough, ME 04074
United States
Phone: (207) 730-5750
Facility Details:
- Property Purchase: August 2020 - $16.95 million for 111,590-square-foot industrial building
- Function: Manufacturing, Research & Development (R&D)
- 2020 Expansion: Facility expanded and renovated to increase production capacity for rapid COVID-19 tests
Secondary Location (FDA Registration):
65 Gannett Drive
Portland, ME 04106
(Registration Number: 3029059580 / FEI: 3029059580)
Leadership Team
- Roger Piasio: Key Principal (per Dun & Bradstreet)
- Damian Halloran: Chief Executive Officer (CEO) - per New York Department of State filing, located at Abbott Park, IL
- Mary Kluck: Official Correspondent (FDA records) - Abbott Diagnostics Scarborough, Inc., 10 Southgate Road, Scarborough, ME 04074
- RACHel Blackwell: Manufacturer Contact (FDA adverse event reports) - 10 Southgate Road, Scarborough, ME 04074, Phone: 661-388-8803
Core Product Portfolio
HIV Diagnostics
Determine HIV-1/2 Ag/Ab Combo (25T):
- Rapid immunoassay for the qualitative detection of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2
- FDA 510(k) Number: BP120037
- Catalog Number: 7D2648
- Used for whole blood, serum, or plasma samples; results in 20 minutes
- Product Code: MZF (IVD for HIV 1/2 AG/AB)
COVID-19 Diagnostics
BinaxNOW COVID-19 Ag Self Test (2CT):
- Visual read lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from nasal swab specimens
- FDA EUA Number: EUA210264 (Emergency Use Authorization)
- Catalog Number: 195-160
- High-sensitivity antibody-based detection system
ID NOW COVID-19:
- Molecular in vitro diagnostic test for qualitative detection of SARS-CoV-2 RNA
- FDA EUA Number: EUA2000074
- Catalog Number: 190-000
- Rapid, instrument-based isothermal nucleic acid amplification test
Influenza Diagnostics
ID NOW Influenza A/B 2.0 (24T):
- Multiplex nucleic acid assay for qualitative detection of Influenza A and Influenza B viral RNA
- FDA 510(k) Number: K171792
- Catalog Number: 427-000
- Real-time isothermal nucleic acid amplification technology
- Product Code: OZE
Bacterial Detection
Clearview PBP2A SA Culture Colony Test:
- System for genotypic detection of resistant markers in Staphylococcus aureus colonies
- Detects methicillin-resistant Staphylococcus aureus (MRSA) / PBP2A protein
- FDA 510(k) Number: K133851
- Catalog Number: 893-000
- Product Code: MYI
Other Diagnostic Products
BinaxNOW G6PD: In vitro diagnostic test for G6PD (Glucose-6-phosphate dehydrogenase) deficiency detection
- FDA 510(k) Number: K080003
- Catalog Number: 780-000
- Product Code: JBF
Regulatory Compliance & Quality
FDA Registration:
- FEI Number: 3029059580 (Firm Establishment Identifier)
- Registration Number: 3029059580
- Status: Active (Date of Registration Status: 2026)
- Owner/Operator: ABBOTT LABORATORIES (Owner/Operator Number: 1415939)
- Official Correspondent: Mary Kluck - Abbott Diagnostics Scarborough, Inc., 10 Southgate Road, Scarborough, ME 04074, Phone: 1-207-730-5750
Quality Management:
- ISO-compliant manufacturing processes (implied by FDA establishment registration and product quality standards)
- Stringent quality control and batch release testing procedures
- Comprehensive complaint monitoring and trend analysis systems
Research & Development
The Scarborough facility maintains active R&D capabilities in rapid diagnostic technologies, evidenced by:
- Patent Portfolio: Assigned patents in recombinase polymerase amplification (RPA), microfluidic devices, and automated nucleic acid amplification systems (per Justia patents database)
- Product Innovation: Development of next-generation ID NOW platform and multiplex testing capabilities
- Manufacturing Excellence: Continuous improvement in production processes for rapid diagnostic test kits
Market Position & Strategic Importance
Pandemic Response Role (2020-2024):
The Scarborough facility became a critical manufacturing hub during the COVID-19 pandemic:
- Rapid scale-up of BinaxNOW COVID-19 Ag Card production following FDA EUA approval in April 2020
- Manufacturing of ID NOW COVID-19 molecular tests for point-of-care settings
- Contribution to national COVID-19 testing capacity expansion
Strategic Value:
- Domestic US manufacturing capacity for essential diagnostic tests
- Integration with Abbott's global Rapid Diagnostics supply chain
- Support for public health initiatives in infectious disease control
Employment & Operations (2025-2026)
Current Job Openings (2025):
- Calibration Technician II: Position availAble in Scarborough, ME (posted 2025) - responsible for calibrating testing and measuring equipment across manufacturing operations, ensuring compliance with Quality Systems Requirements
- Base pay range: $19.85 - $39.65 per hour (2025 data)
Operational Status:
- Active manufacturing and R&D operations as of April 2026
- Part of Abbott Rapid Dx North America business unit
- Ongoing production of Determine HIV tests, ID NOW platforms, and other rapid diagnostics
Contact Information
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
United States
Phone: (207) 730-5750
Parent Company Website: www.abbott.com
Global Diagnostics Info: www.globalpointofcare.abbott
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