Bio/Data Corporation has spent more than five decades manufacturing platelet aggregometers and related testing solutions for hemostasis and platelet-function laboratories. Its history includes introducing the world’s first automated Platelet Aggregometer in 1974 and developing the eight-channel PAP-8E, while its U.S.-manufactured products are supported by factory service and technical assistance. The Horsham company has maintained ISO 13485 registration since 2006 and also supplies specimen-handling products for laboratory workflows.
ISO 13485 Registration
Registration
ISO 9001:2000 Registration
Registration
FDA Quality System Regulation, Title 21 CFR Section 820
Compliance program
EU In Vitro Diagnostic Regulation (IVDR) 2017/746
Compliance program
UKCA Statutory Regulations
Compliance program
FDA Registration and Certificate to Foreign Government
Compliance program
FDAQSR
Quality certification
EUIVDR
Quality certification