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(Logo Graphic) Office of In Vitro Diagnostic Device Evaluation and Safety OIVD

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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
* New CeSub Turbo 510(k)
* New Suggested Analytical Testing
Protocol For IVD Devices Manufactured
With Contaminated Heparin
* Code of Federal Regulations (CFR)
  Overview of IVD Regulation
  Guidance Documents
  IVD Standards
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Home and Lab Tests

New Reporting Glucose Device Problems


Rapid Lead Screening Test

* Glossary of Terms
  Home-Use Tests

Lab Tests

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  Find All FDA-Approved Home & Lab Tests
About Us
  Office Information
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  OIVD Annual Reports
In Vitro Device News
(Updated Jan. 16, 2009)
FDA Publishes a New Guidance Document on Assay Migration Studies for IVDs
FDA Issued a Warning Letter to the CEO of LabCorp Regarding The Illegal Marketing of The OvaSure™ Test
FDA Clears New CDC Test to Detect Human Influenza
FDA invites the CEO of LabCorp to discuss strategies for clinical validation of the OvaSure™ Test.
  More OIVD News

Updated January 16, 2009

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