CytoCell

Basic Information

• Brand Name: CytoCell
• Primary DI: 05055844934894
• Version / Model: CDA-LPH013
• Company Name: CYTOCELL LIMITED
• Labeler DUNS: 232477914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-22
• Public Version: 1
• Public Version Date: 2025-09-30
• Public Version Status: New
• Public Device Record Key: a0e9a291-4725-45ea-a5f0-a3eb1fd1b8d5

Device Description

KMT2A Breakapart FISH Probe Kit PDx

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SFS	Revumenib Eligibility Detection System	Hematology	864.1885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60079	Acute myeloid leukaemia (AML) genetic mutation IVD, probe	A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).	No	Active
62955	B-cell malignancy IVD, probe	A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to detect and/or monitor B-cell malignancies. Genetic changes associated with B-cell malignancies are typically associated with chromosomal translocations and gene rearrangements involving various genes/loci such as cyclin D1 (CCND1), immunoglobulin heavy or light chain genes (e.g., IGH, IGK, IGL), myc, and B-cell lymphoma genes (e.g., BCL1, BCL2).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055844934894	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN240067	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store the probe vial in the dark. Ensure that exposure of the probe to laboratory lights is limited at all times