FDA guidance
Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface…
FDA guidance · Final · issued Nov 21, 2007
Key facts
| Title | Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Nov 21, 2007 |
| Center | Center for Biologics Evaluation and Research |
| Issuing office | Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics |
| Docket number | FDA-2002-D-0175 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents