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Bio-Rad received 510(k) clearance for its IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents.
The FDA said it observed a number of violations of federal law related to the company's Vacutainer blood collection tubes during an inspection.
The device is based on a proprietary technology that involves extracting a protein called fibroin from silk fibers.
The firm's transplant allograft status test identifies genetic biomarkers that predict the likelihood of a patient's immune system to reject the organ over time.
The XW-100 Automated Hematology Analyzer previously received 510(k) clearance. With the CLIA waiver, the test can be run in more types of healthcare facilities.
Siemens noted that in closing the acquisition of Epocal, the former Alere subsidiary, it has also completed its own blood gas portfolio.
The investment is part of a Series C financing round that will also include other investors. Seventh Sense is developing a new type of blood collection device to improve patient compliance.
OIG will evaluate data to assess whether PAMA pricing results in market-based rates
The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.
The company aims to wrap up field trials for the system by the end of this year and will seek European regulatory clearance thereafter.