Celiac Disease Test

FDA UDI

Class II (US FDA UDI)

by Cue Health Inc.

Identity

Trade Name: Celiac Disease Test FDA UDI
Generic Name: Capillary blood collection kit IVD FDA UDI
Device Name: Cue Sample Collection Kit, Blood (Adx Single), Celiac Disease Screening Test FDA UDI
Model / Reference: C2247 FDA UDI
Description: Cue Sample Collection Kit, Blood (Adx Single), Celiac Disease Screening Test FDA UDI

Identifiers

Primary DI / UDI-DI: 00810040821042 FDA UDI
FDA Product Code: PQD FDA UDI
GMDN Term: Capillary blood collection kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 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

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

Celiac Disease Test by Cue Health Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Cue Health Inc.

Sources (1)

FDA UDI 85bbf22b-56bc-49c7-b668-af4684c0349b 33 fields · synced May 31, 2026