CytoCell

Basic Information

• Brand Name: CytoCell
• Primary DI: 05055844923850
• Version / Model: USA-LPH020
• Company Name: CYTOCELL LIMITED
• Labeler DUNS: 232477914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-26
• Public Version: 1
• Public Version Date: 2025-04-03
• Public Version Status: New
• Public Device Record Key: 60d5658b-1d13-4f0d-bbb3-1168888dab99

Device Description

Del(20q) Deletion FISH Probe Kit (IVD (USA))

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
QDI	Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies	Medical Genetics	864.1880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61681	Myelodysplastic syndrome (MDS) 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 evaluate a clinical specimen to diagnose, monitor or predict myelodysplastic syndrome (MDS) based on changes at the gene or chromosome level, which may include deletion of the q arm of chromosome 20.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055844923850	GS1
Previous	05055844905948	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN170070	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.