Bladder EpiCheck Test Kit

Basic Information

• Brand Name: Bladder EpiCheck Test Kit
• Primary DI: 07290019028208
• Version / Model: 02
• Catalog Number: NX899090-02US
• Company Name: NUCLEIX LTD
• Labeler DUNS: 532498271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-13
• Public Version: 1
• Public Version Date: 2023-10-23
• Public Version Status: New
• Public Device Record Key: 87bda168-b673-4016-af76-cf249ce8e489

Device Characteristics

• Single Use: Yes
• 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
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59010	Methylated DNA IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials (e.g., software) intended to be used for the qualitative and/or quantitative detection of methylated DNA in a clinical specimen. Methylated DNA and DNA methylation patterns in specific genes or genomic regions are typically associated with the development of cancer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019028208	GS1

Premarket Submissions

Submission Number	Supplement Number
K203245	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius