CytoCell
GUDID 05060180988739
IGH/BCL2 Translocation, Dual Fusion Probe
CYTOCELL LIMITED
Assay development analyte-specific reagent IVD| Primary Device ID | 05060180988739 |
| NIH Device Record Key | 3edd3606-fc7f-4fe6-b343-72109628d9c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CytoCell |
| Version Model Number | LPS033-A |
| Company DUNS | 232477914 |
| Company Name | CYTOCELL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 | 05060180988739 [Primary] |
FDA Product Code
| MVU | Reagents, Specific, Analyte |
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 | 2022-09-09 |
| Device Publish Date | 2022-09-01 |
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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