Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Total bilirubin IVD, calibrator FDA UDI
Device Name: Bilirubin Calibrator FDA UDI
Model / Reference: 1E66-05 FDA UDI
Description: Bilirubin Calibrator FDA UDI

Identifiers

Catalog Number: 01E6605 FDA UDI
Primary DI / UDI-DI: 00380740161385 FDA UDI
FDA Product Code: JIX FDA UDI
GMDN Term: Total bilirubin IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

Yes

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, calibrator

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

Similar devices

Also classified as Total bilirubin IVD, calibrator.

Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution — Advanced Instruments, LLC · Class II
Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution — Advanced Instruments, LLC · Class II
Alinity — Abbott · 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 8f31bed4-caf3-4382-9031-6f56403550b5 36 fields · synced Jun 8, 2026