CytoCell

Basic Information

• Brand Name: CytoCell
• Primary DI: 05055844905900
• Version / Model: USA-LPH026
• Catalog Number: USA-LPH026
• Company Name: CYTOCELL LIMITED
• Labeler DUNS: 232477914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: 32dc83c4-c48f-44d2-8a1f-9bb4574174d8

Device Description

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

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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055844905900	GS1
Previous	05055844901520	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 and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lights is limited at all times.