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GUIDANCE DOCUMENT

Draft Recommended Methods for Blood Grouping Reagents Evaluation March 1992

Final
Docket Number:
84S-0181
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In follow-up to the 7-9 November 1990 workshop "REAGENTS FOR THE 1990's", the comments received from licensed manufacturers of Blood Grouping Reagents, users, and other interested parties concerning "Proposed Revised Performance Criteria for Anti-Human Globulin Reagents" were reviewed and incorporated into this document. A summary of the changes that have been made is included on page (ii).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 84S-0181.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010