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Bladder EpiCheck Test Kit

FDA UDI

Class II (US FDA UDI)

by Nucleix , Ltd.

Identity

Trade Name
Bladder EpiCheck Test Kit FDA UDI
Generic Name
Methylated DNA IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
02 FDA UDI

Identifiers

Catalog Number
NX899090-02US FDA UDI
Primary DI / UDI-DI
07290019028208 FDA UDI
510(k) Number
K203245 FDA UDI
FDA Product Code
MMW FDA UDI
GMDN Term
Methylated DNA IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Methylated DNA IVD, kit, nucleic acid technique (NAT)

Bladder EpiCheck Test Kit by Nucleix , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Methylated DNA IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K203245 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nucleix , Ltd.

Sources (1)

  • FDA UDI 87bda168-b673-4016-af76-cf249ce8e489 35 fields · synced May 30, 2026