OXP · Class II · 21 CFR 866.6010

FDA Product Code OXP: Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment

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.

1
Total
1
Cleared
502d
Avg days
1997
Since

FDA 510(k) Cleared Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment Devices (Product Code OXP)

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About Product Code OXP - Regulatory Context