Cytocell Aquarius USA-LPH026

GUDID 05055844901520

AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit

CYTOCELL LIMITED

Acute myeloid leukaemia (AML) genetic mutation IVD, probe

• Primary Device ID: 05055844901520
• NIH Device Record Key: 9cc85c66-8477-4ba2-9ffc-07fc2a2c9310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytocell Aquarius
• Version Model Number: USA-LPH026
• Catalog Number: USA-LPH026
• 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
• Email: probes@cytocell.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05055844901520 [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: 2019-02-28
• Device Publish Date: 2019-01-28

On-Brand Devices [Cytocell Aquarius]

• 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