BD BACTEC™ Plus Aerobic/F Blood Culture Plastic Bottles Receive FDA Clearance
Contact: Jamie Yacco
Baltimore, MD (July 17, 2012) – BD Diagnostics, a segment of BD (Becton, Dickinson and Company), today announced that it obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for BD BACTEC™ Plus Aerobic/F blood culture bottles in plastic, previously only available in glass. Obtaining 510(k) clearance allows for increased convenience for customers without compromising the performance and quality of the system.
"BD is pleased to offer our customers the convenience of plastic, while continuing to deliver outstanding performance and rapid time-to-detection that drive better sepsis and healthcare-associated infection diagnostics,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems. “FDA clearance of the BD BACTEC Plus Aerobic/F blood culture plastic bottles represents BD’s commitment to meeting customer needs without compromising clinical performance.”
BD BACTEC Plus Aerobic/F blood culture plastic bottles provide customers with leading organism recovery through antibiotic neutralization and clear gram stain readability. The bottles run on currently available BD BACTEC™ systems, offering customers proven laboratory efficiency with optimized workflow and data management. The BD BACTEC™ Blood Culture System is a fully-automated microbiology growth and detection system designed to detect microbial growth from blood specimens. Top-notch performance is preserved along with rapid time-to-detection, enabling better diagnostics and patient care.
For more information on BD Blood Culture Systems, please visit http://www.bd.com/europe/ds/sepsis/
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.