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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dna-probe kit, human chromosome x and y, bmt engraftment
Regulation Description Tumor-associated antigen immunological test system.
Definition X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
Product CodeOXP
Regulation Number 866.6010
Device Class 2