FDA Clears Ready-to-Use PK System Blood Grouping and Phenotyping Reagents for the PK 7200®
Center Valley, Pa., January 14, 2008 — Olympus America Inc., the leading provider of high-throughput automated blood bank instruments in the North America donor market since the 1980s, today announced that the U.S. Food and Drug Administration (FDA) has approved the ready-to-use PK® Blood Grouping Reagents for its Olympus PK7200 Automated Microplate System. The new reagents standardize ABO/Rh testing on the PK7200 and are convenient, economical, and efficient.
The new antisera and reagent red blood cells are packaged in ready-to-use vials. No handling or manipulation of the reagents will be required other than transferring them to the appropriate locations on the PK7200 reagent boat. The color-coded reagents enhance process control, by enabling quick visual verification of reagent placement.
The reagents are pre-qualified and standardized for optimal performance reducing variability of manually prepared reagents. The elimination of dilution studies provides lot-to-lot consistency and elimination of troubleshooting issues related to in-house manufactured reagents.
For more information on the Olympus PK System Blood Grouping and Phenotyping Reagents, contact Amy Spizzirri, Olympus America Inc.; phone: 484-896-5244; email firstname.lastname@example.org.
About Olympus Diagnostic Systems
Olympus Diagnostic Systems provides innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks and pharmaceutical labs. Olympus offers the broadest standardized line of random access chemistry-immuno analyzers, along with lab automation systems, blood bank analyzers and reagents. Olympus solutions save laboratories time, maximize productivity, and deliver fast, reliable results.
Olympus is a precision technology leader, creating innovative opto-digital solutions in healthcare, life science and consumer electronics products. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include:
- Gastrointestinal endoscopes, accessories, and minimally invasive surgical products;
- Advanced clinical and research microscopes;
- Lab automation systems, chemistry-immuno and blood bank analyzers and reagents;
- Digital cameras and voice recorders.
Olympus serves healthcare and commercial laboratory markets with integrated product solutions and financial, educational and consulting services that help customers to efficiently, reliably and more easily achieve exceptional results. Olympus develops breakthrough technologies with revolutionary product design and functionality for the consumer and professional photography markets, and also is the leader in gastrointestinal endoscopy and clinical and educational microscopes. For more information, visit www.olympusamerica.com.