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Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

FDA product code OXP · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6010
Review panel
PA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1997-01-21 – 1997-01-21

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.

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