| Primary Device ID | 05055844901599 |
| NIH Device Record Key | b7e1d70d-3a94-4733-86d8-28d6b8ea1f3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cytocell Aquarius |
| Version Model Number | USA-LPH013 |
| Catalog Number | USA-LPH013 |
| Company DUNS | 232477914 |
| Company Name | CYTOCELL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 914 467 5285 |
| probes@cytocell.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times. |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055844901599 [Primary] |
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-28 |
| Device Publish Date | 2019-01-28 |
| 05055844901605 | P53 (TP53) Deletion FISH Probe Kit |
| 05055844901599 | MLL (KMT2A) Breakapart FISH Probe Kit |
| 05055844901582 | EVI1 (MECOM) Breakapart FISH Probe Kit |
| 05055844901575 | Del(20q) Deletion FISH Probe Kit |
| 05055844901568 | Del(7q) Deletion FISH Probe Kit |
| 05055844901551 | Del(5q) Deletion FISH Probe Kit |
| 05055844901544 | CBFβ (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit |
| 05055844901520 | AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit |