RenalytixAI Urine Collection Kit

FDA UDI

Class I (US FDA UDI)

by Renalytixai

Identity

Trade Name: RenalytixAI Urine Collection Kit FDA UDI
Generic Name: General specimen collection kit FDA UDI
Device Name: Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing FDA UDI
Model / Reference: RENX3011003 FDA UDI
Description: Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing FDA UDI

Identifiers

Primary DI / UDI-DI: 00860009877917 FDA UDI
FDA Product Code: OIE FDA UDI
GMDN Term: General specimen collection kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General specimen collection kit

RenalytixAI Urine Collection Kit by Renalytixai — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Renalytixai

Sources (1)

FDA UDI 75f43196-36e1-4eb8-9cb5-1f045d969a82 35 fields · synced May 31, 2026