Abbott Diagnostics Scarborough, Inc. - US Manufacturing Hub for Rapid Diagnostics and Point-of-Care

📢 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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