| 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. |
| Physical State |
Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders |
| Technical Method |
fluorescence in situ hybridization (FISH) |
| Target Area |
opposite-sex bone marrow transplantation for hematological disorders |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Hematology |
|---|
| Product Code | OXP |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6010
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
