# Assay Migration Studies for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/assay-migration-studies-for-in-vitro-diagnostic-devices-guidance-for-industry-and-fda-staff/7800aabf-40dc-4ade-890e-83c1ec312a77

> FDA guidance document: Assay Migration Studies for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff. Issue date: April 25, 2013. Get complete insights and analysis.

---

## Details

- Title: Assay Migration Studies for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2013-04-25
- Last Changed: 2020-02-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0642">FDA-2008-D-0642</a>

## Related Documents

- [Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/distribution-of-in-vitro-diagnostic-products-labeled-for-research-use-only-or-investigational-use-only-guidance-for-industry-and-fda-staff/dd8e1483-1883-474d-925f-8579c62a5379)
- [Molecular Diagnostic Instruments with Combined Functions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/molecular-diagnostic-instruments-with-combined-functions-guidance-for-industry-and-food-and-drug-administration-staff/a574268b-28c8-40e2-8ea4-60887b411baf)
- [In Vitro Companion Diagnostic Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/in-vitro-companion-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/18915018-e22e-4930-90ea-2f601a510495)
