Primary Device ID | 05055844901544 |
NIH Device Record Key | 5a6910b1-0718-4943-9d19-d03e3260d0e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cytocell Aquarius |
Version Model Number | USA-LPH022 |
Catalog Number | USA-LPH022 |
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 | 05055844901544 [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 |