The following data is part of a De Novo classification by Cytocell Ltd with the FDA for Mll (kmt2a) Breakapart Fish Probe Kit; Aml1 (runx1) Breakapart Fish Probe Kit, P53 (tp53) Deletion Fish Probe Kit; Evi1 (mecom) Breakapart Fish Probe Kit, Del(20q) Deletion Fish Probe Kit; Aml1/eto (runx1/runxit1)) Translocation, Dual Fusi, Cbfb (cbfb) /myh11 Translocation, Dual Fusion Fish Probe K.
| DeNovo ID | DEN170070 |
| Device Name: | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe K |
| Classification | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
| Applicant | Cytocell Ltd 3-4 Technopark, Newmarket Road Cambridge, GB Cb5 8pb |
| Contact | Xavier Baker |
| Product Code | QDI |
| CFR Regulation Number | 864.1880 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Molecular Genetics |
| Classification Advisory | Molecular Genetics |
| Type | Direct |
| Date Received | 2017-09-29 |
| Decision Date | 2018-12-21 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055844901605 | DEN170070 | 000 |
| 05055844905924 | DEN170070 | 000 |
| 05055844905917 | DEN170070 | 000 |
| 05055844905900 | DEN170070 | 000 |
| 05055844923904 | DEN170070 | 000 |
| 05055844923898 | DEN170070 | 000 |
| 05055844923881 | DEN170070 | 000 |
| 05055844923874 | DEN170070 | 000 |
| 05055844923867 | DEN170070 | 000 |
| 05055844923850 | DEN170070 | 000 |
| 05055844923843 | DEN170070 | 000 |
| 05055844905931 | DEN170070 | 000 |
| 05055844905948 | DEN170070 | 000 |
| 05055844901599 | DEN170070 | 000 |
| 05055844901582 | DEN170070 | 000 |
| 05055844901575 | DEN170070 | 000 |
| 05055844901568 | DEN170070 | 000 |
| 05055844901551 | DEN170070 | 000 |
| 05055844901544 | DEN170070 | 000 |
| 05055844901520 | DEN170070 | 000 |
| 05055844905979 | DEN170070 | 000 |
| 05055844905962 | DEN170070 | 000 |
| 05055844905955 | DEN170070 | 000 |
| 05055844923836 | DEN170070 | 000 |