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Medical Devices
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In Vitro Diagnostics
In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
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News & Events
- FDA Posts Notice On GDH-PQQ Glucose Test Systems
- Revelations in In Vitro Diagnostic (IVD) Device Labeling - Proactive Prevention of Adverse Events by Informed Decision Making
- FDA Publishes a New Guidance Document on Assay Migration Studies for IVDs
- FDA Clears New CDC Test to Detect Human Influenza
- Archived OIVD News Items
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Approvals & Clearances
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Contact Us
- 301-796-5450
CDRH-Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993
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