Lab Developed Tests

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18 09, 2015

FDA Regulation of Lab Developed Tests – Keeping Track of the Dialogue

By |September 18th, 2015|Infectious Diseases, Lab Developed Tests|Comments Off on FDA Regulation of Lab Developed Tests – Keeping Track of the Dialogue

The U.S. Food and Drug Administration (FDA) defines a Laboratory Developed Test (LDT) as “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory”. While some LDTs are relatively simple tests that measure single analytes, others are complex and measure or detect numerous analytes. Examples of LDTs include [...]

20 07, 2015

Block Scientific to Attend AACC Clinical Lab Expo 2015

By |July 20th, 2015|Lab Developed Tests, Lab Equipment|Comments Off on Block Scientific to Attend AACC Clinical Lab Expo 2015

Block Scientific, a leading laboratory equipment supplier based in New York, is attending the 2015 AACC (American Association for Clinical Chemistry) Clinical Lab Expo in Atlanta, Georgia. This leading event for laboratory medicine worldwide is to be held from July 26-30. With more than 700 companies exhibiting, the Expo is the world’s largest exposition for [...]

10 09, 2014

FDA to Regulate More Lab Developed Tests

By |September 10th, 2014|Lab Developed Tests|Comments Off on FDA to Regulate More Lab Developed Tests

The FDA has proposed a new regulatory plan to oversee potentially thousands of laboratory-developed medical tests that the agency contends may be prone to errors. In an announcement made on July 2014, the U.S. Food and Drug Administration has made it clear that for the first time it will regulate many diagnostic tests, especially for [...]