Kidney Function Test

FDA UDI

by Cue Health Inc.

Identity

Trade Name: Kidney Function Test FDA UDI
Generic Name: Capillary blood collection kit IVD FDA UDI
Device Name: Sample Collection Kit, Blood (Adx Single), Kidney Panel FDA UDI
Model / Reference: C2236 FDA UDI
Description: Sample Collection Kit, Blood (Adx Single), Kidney Panel FDA UDI

Identifiers

Primary DI / UDI-DI: 00810040821004 FDA UDI
GMDN Term: Capillary blood collection kit IVD FDA UDI

Classification

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

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Capillary blood collection kit IVD

Kidney Function Test by Cue Health Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Capillary blood collection kit IVD.

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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	N/A	Pending data

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Manufacturer

Manufacturer: Cue Health Inc.

Sources (1)

FDA UDI 9d9fa0e1-cd48-4b71-83d9-abef9a513e8c 33 fields · synced Jun 1, 2026