Immucor ABS 2000 automated blood bank system clinical trials under way.
This article was originally published in The Gray Sheet
Executive SummaryIMMUCOR ABS 2000 AUTOMATED BLOOD BANK SYSTEM 510(K) SUBMISSION planned following completion of clinical trials, which are expected to take approximately four to six months, the Norcross, Georgia firm says. Trials for the device, used to perform ABO/Rh blood grouping, antibody screening and patient crossmatching, began the week of Sept. 4 at five blood bank transfusion service laboratories. The five labs include three university hospitals, a smaller, non-university hospital, and one donor/transfusion service lab. Trials at two other primary care facilities are expected to commence in the next few weeks.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.