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5374. Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

5377. 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

5378. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff