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Medical Devices / Submissions and Approvals

FDA Clears Qiagen's QuantiFeron-TB Gold Plus Blood Testing Device

June 12, 2017
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Qiagen has gained FDA marketing clearance for its QuantiFeron-TB Gold Plus (QFT-Plus), the fourth generation of its blood test for detecting latent tuberculosis infection.

The device measures a broader range of immune responses. The test includes a standard single-tube blood collection option which allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test.

Qiagen plans to launch of the device in the United States later this year. — Cynthia Jessup

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