Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Device Name: Total Bilirubin FDA UDI
Model / Reference: 6L45-22 FDA UDI
Description: Total Bilirubin FDA UDI

Identifiers

Catalog Number: 06L4522 FDA UDI
Primary DI / UDI-DI: 00380740174965 FDA UDI
FDA Product Code: CIG FDA UDI
MQM FDA UDI
GMDN Term: Total bilirubin IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1110 FDA UDI
862.1113 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

Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total bilirubin IVD, kit, spectrophotometry.

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CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT BL-228 — Carolina Liquid Chemistries Corp. · Class II
ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents — Siemens Healthcare Diagnostics · Class I
Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
Bilirubin Total Gen.3 — Roche Diagnostics Corp. · Class II
TOTAL BILIRUBIN-SL-X — Sekisui Diagnostics, LLC · Class II
Alinity — ABBOTT IRELAND · Class I
Direct Bilirubin — Roche Diagnostics Corp. · Class II

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: Abbott

Sources (1)

FDA UDI 5b6c0efc-de3d-40ba-9158-2e1c044b7765 36 fields · synced Jun 7, 2026