Pioneer in Point of Care Diagnostic Products and Technology
Princeton BioMeditech Corporation (PBM) is a world leader in rapid, point-of-care diagnostics. PBM develops and manufactures high quality and innovative products for consumer in-home use and professional on-site/point-of-care use. From the one-step pregnancy test to the rapid, 3-in-1 cardiac marker panel, and now rapid, quantitative Troponin I, PBM has introduced professionals and consumers around the world to the speed, ease of use and reliability of rapid, point of care diagnostics. Utilizing its patented technologies, PBM has developed and introduced an extensive menu of over 70 different rapid tests. With products in the areas of Fertility, Infectious Diseases, Drugs of Abuse, Tumor Markers, Cardiac Markers, Veterinary Diagnostics and Food and Environmental Diagnostics, PBM manufactures a wider range of simple, easy-to-use tests than any other company.
Our mission is to cost-effectively provide the highest quality diagnostic products and services to customers around the world. In doing so, we focus on responding to our customers’ needs with excellence and total quality, continual improvement, and compliance with quality standards and regulatory requirements.
Professionals in doctors’ offices, laboratories and clinics around the world trust PBM products for their diagnostic testing needs. PBM products are available in over 48 countries through local and national distributors, through retailers and through partnerships with leading pharmaceutical and diagnostic companies.
Our simple and rapid immunoassay technology has been patented in the U.S. and other countries around the world. AccuSign®, BioSign®, BioStrep®, BioStrip®, LifeSign®, OvuSign®, and StatusFirst® are trademarks of Princeton BioMeditech Corporation registered in the U.S. and other countries.
Quality and Regulatory Compliance
PBM’s manufacturing facility is a registered FDA Medical Device Establishment operating under current Good Manufacturing Practices (cGMP). PBM’s quality system is certified under ISO 13485:2016 and is periodically inspected by third party auditors to verify conformity with these standards and regulations, further assuring high quality products and services. PBM markets products with FDA 510(k) clearance in the U.S., CMDCAS in Canada, CE mark (IVDD 98/79/EC) in the European Union and other regulatory approvals and registrations as necessary in various countries. See the Regulatory page to download ISO certificates. Please let us know how we can assist you.
ISO 13485:2016 certificate (PDF, 132 KB)
EC certificate (IVDD 98/79/EC) (PDF, 393 KB)
MDSAP certificate (PDF, 152 KB)