Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
- US Product Code (FDA)
- OXPView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.6010View CFR Regulation →
- Medical specialty
- Immunology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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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Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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