Alinity

FDA UDI

Class I (US FDA UDI)

by Abbott Ireland

Identity

Trade Name: Alinity FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Device Name: Total Bilirubin2 3500 Tests FDA UDI
Model / Reference: 04U0520 FDA UDI
Description: Total Bilirubin2 3500 Tests FDA UDI

Identifiers

Catalog Number: 04U0520 FDA UDI
Primary DI / UDI-DI: 00380740167585 FDA UDI
FDA Product Code: MQM FDA UDI
CIG FDA UDI
GMDN Term: Total bilirubin IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1113 FDA UDI
862.1110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total bilirubin IVD, kit, spectrophotometry

Alinity by Abbott Ireland — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
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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: Abbott Ireland

Sources (1)

FDA UDI bed3f4fc-a477-4da4-8478-a4fd20e97b9f 36 fields · synced May 30, 2026