CytoCell USA-LPH036
GUDID 05055844905955
EVI1 (MECOM) Breakapart FISH Probe Kit
CYTOCELL LIMITED
Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe Acute myeloid leukaemia (AML) genetic mutation IVD, probe| Primary Device ID | 05055844905955 |
| NIH Device Record Key | 29df6df5-6e1e-4bdb-8d75-6ed0b6769835 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CytoCell |
| Version Model Number | USA-LPH036 |
| Catalog Number | USA-LPH036 |
| 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 |
Customer Support Contacts
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com | |
| Phone | 914 467 5285 |
| probes@cytocell.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055844901582 [Previous] |
| GS1 | 05055844905955 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN170070
FDA Product Code
| QDI | Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-20 |
| Device Publish Date | 2021-07-12 |
On-Brand Devices [CytoCell]
| 05055844905979 | P53 (TP53) Deletion FISH Probe Kit |
| 05055844905962 | MLL (KMT2A) Breakapart FISH Probe Kit |
| 05055844905955 | EVI1 (MECOM) Breakapart FISH Probe Kit |
| 05055844905948 | Del(20q) Deletion FISH Probe Kit |
| 05055844905931 | Del(7q) Deletion FISH Probe Kit |
| 05055844905924 | Del(5q) Deletion FISH Probe Kit |
| 05055844905917 | CBFß (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit |
| 05055844905900 | AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit |
| 05060180989996 | AFF1 Probe |
| 05060180989989 | MLL Probe |
| 05060180989972 | HLF Probe |
| 05060180989965 | PBX1 Probe |
| 05060180989958 | E2A Probe |
| 05060180989651 | Alpha Satellite 12 Plus |
| 05060180989248 | P2RY8 Proximal Probe |
| 05060180989231 | P2RY8 Distal Probe |
| 05060180989224 | CRLF2 Proximal Probe |
| 05060180989217 | CRLF2 Distal Probe |
| 05060180989194 | D13S319 Plus Deletion Probe |
| 05060180989071 | RARα Distal Probe |
| 05060180989064 | RARα Proximal Probe |
| 05060180989057 | FAST RARα Probe |
| 05060180989040 | FAST PML Probe |
| 05060180988913 | IGL Breakapart Probe |
| 05060180988883 | IGK Breakapart Probe |
| 05060180988852 | P53 Deletion Probe |
| 05060180988821 | P16 Deletion Probe |
| 05060180988791 | IGH/MYC Translocation, Dual Fusion Probe |
| 05060180988760 | IGH/MALT1 Translocation, Dual Fusion Probe |
| 05060180988739 | IGH/BCL2 Translocation, Dual Fusion Probe |
| 05060180988708 | IGH Breakapart Probe |
| 05060180988678 | IGH/CCND1 Translocation, Dual Fusion Probe |
| 05060180988647 | CCND1 Breakapart Probe |
| 05060180988616 | BCL6 Breakapart Probe |
| 05060180988586 | BCL2 Breakapart Probe |
| 05060180988555 | MYC Breakapart Probe |
| 05060180988289 | ROS1 Breakapart Probe |
| 05060180988227 | MALT1 Probe |
| 05060180988210 | API2 Probe |
| 05060180988050 | Chromosome 17 Alpha Satellite Probe (Concentrated) |
| 05060180988043 | Chromosome 12 Alpha Satellite Probe (Concentrated) |
| 05060180988029 | ERG Control Probe |
| 05060180988012 | TMPRSS2 Breakapart Probe |
| 05060180987985 | EML4 Breakapart Probe |
| 05060180987954 | ALK Breakapart Probe |
| 05060180987312 | P53/ATM Probe Combination |
| 05060180986841 | 2qter Subtelomere Specific Probe non-polymorphic clone (Concentrated) |
| 05060180986834 | 2qter Subtelomere Specific Probe non-polymorphic clone (Concentrated) |
| 05060180986810 | Chromosome X Alpha and Y Classical Satellite Probes |
| 05060180986803 | Chromosome X Alpha and Y Alpha Satellite Probes |
Trademark Results [CytoCell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTOCELL 77925254 4143131 Live/Registered |
UNILEVER N.V. 2010-02-01 |
 CYTOCELL 77581075 not registered Dead/Abandoned |
Cytogenix Sports Laboratories SRL 2008-09-29 |
 CYTOCELL 74427925 not registered Dead/Abandoned |
Pharmacia Bioprocess AB 1993-08-23 |
 CYTOCELL 74412995 1980347 Live/Registered |
CYTOCELL LIMITED 1993-07-15 |
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