Founded in 2017, KSL Biomedical develops and manufactures diagnostic tests while providing contract research, clinical, quality, and regulatory services for medical-device and in-vitro diagnostic companies. Based in Buffalo, New York, the company combines its own assay development and New York State manufacturing with integrated clinical laboratories in the United States and Canada. Its team includes specialists who have taken more than 50 assays and medical devices through validation and FDA 510(k) clearance.
ISO 13485 Certification
Health Canada License
Registration
College of American Pathologists (CAP) Accreditation
CLIA License
Registration
New York State Department of Health Approval
CAP
Quality certification
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD
Rookery LabsRookery Labs operates a Western New York innovation incubator for medical-device research, development, and engineering. Based in Buffalo, the company brings researchers, engineers, and healthcare professionals together while developing medical-technology talent and supporting healthcare ventures. Its quality system is certified to ISO 13485.BUFFALO, NY
You First Services Group of CompaniesFormed to move promising laboratory discoveries into practical healthcare use, You First Services Group of Companies is a Western New York research and manufacturing company. Its Buffalo operation includes a cGMP-compliant pharmaceutical facility, while its research work at the University at Buffalo has produced technologies such as SteriSpace for hospitals, schools and other indoor settings.BUFFALO, NY
UFC Biotechnology, IncFounded in 2012, UFC Biotechnology is a Niagara Falls, New York manufacturer serving scientists, clinicians, and pharmaceutical professionals with documented laboratory reagents. Its U.S.-made products are third-party tested and released with Certificates of Analysis and Safety Data Sheets.AMHERST, NY