Research Catalog

Details

Additional authors

1. Center for Biologics Evaluation and Research (U.S.)

Description

1. i, 5 p. : digital, PDF file.

Alternative title

1. Revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors

Subject

1. Microbiological assay > Government policy > United States
2. Blood donors > Government policy > United States

Call number

1. GPO Internet HE 20.4802:IN 8/3

Note

1. Title from PDF title page (viewed on May 29, 2009).
2. "July 2001".

Bibliography (note)

1. Includes bibliographical references (p. 5).

System details (note)

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/29/09: http://www.fda.gov/cber/gdlns/bldbrn.pdf ; current access is available via PURL.

Title

1. Guidance for industry [electronic resource] : revised recommendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors.

Imprint

1. Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001]

System details

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/29/09: http://www.fda.gov/cber/gdlns/bldbrn.pdf ; current access is available via PURL.

Bibliography

1. Includes bibliographical references (p. 5).

Connect to:

1. http://purl.access.gpo.gov/GPO/LPS113257

Added author

1. Center for Biologics Evaluation and Research (U.S.)

Gpo item no.

1. 0499-T-02 (online)

Sudoc no.

1. HE 20.4802:IN 8/3

Research call number

1. GPO Internet HE 20.4802:IN 8/3