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Welcome to the Office of In Vitro
Diagnostic Device (OIVD) Evaluation and Safety Web Site

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Regulatory Assistance
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New Rapid Lead Screening Test
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In Vitro Device News
(Updated 10/18/2006)
• Upcoming OIVD’s Immunology Devices Panel Meeting
• FDA Issues Nationwide Alert on Counterfeit Blood Glucose Test Strips
• FDA Waives the LeadCare II Blood Lead Test System to broaden Access to Lead Testing
• FDA Clarifies the Analyte Specific Reagents (ASRs) Rule and its Requirements
• FDA Publishes a New Draft Guidance Document for In Vitro Diagnostic Multivariate Index Assays
• FTC, FDA, and CDC Issue a Public Message About the Facts on At-Home Genetic Tests
  More OIVD News

Updated October 18, 2006

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