AccessGUDID - DEVICE: Bladder EpiCheck Test Kit (07290019028208)

GUDID

Device Identifier (DI) Information

Brand Name: Bladder EpiCheck Test Kit
Version or Model: 02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NX899090-02US
Company Name: NUCLEIX LTD

Primary DI Number: 07290019028208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532498271 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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 (e.g., from cell-free DNA or circulating tumour DNA screening) in a clinical specimen. Methylated DNA and DNA methylation patterns in specific genes or genomic regions are typically associated with the development of cancer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMW	System, Test, Tumor Marker, Monitoring, Bladder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203245	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and -15 Degrees Celsius
Handling Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 87bda168-b673-4016-af76-cf249ce8e489
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: October 13, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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