Bladder EpiCheck Extraction Kit

Basic Information

• Brand Name: Bladder EpiCheck Extraction Kit
• Primary DI: 07290019028000
• Version / Model: 01
• Catalog Number: NX899090-01-US
• 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: ff68e7e9-5a3a-4e1c-897d-ac82a3ee2ca7

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
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019028000	GS1

Premarket Submissions

Submission Number	Supplement Number
K203245	000

Storage Conditions

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