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4531. Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2020
Subject(s):
Blood Transfusion -- standards
HTLV-I Antibodies -- blood
HTLV-II Antibodies -- blood
HTLV-I Infections -- transmission
HTLV-II Infections -- transmission
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4534. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):
Clinical Laboratory Techniques -- standards
Diagnostic Errors
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4535. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):
Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.