Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Ferritin IVD, calibrator FDA UDI
Device Name: Quantia Ferritin Calibrators FDA UDI
Model / Reference: 06K4904 FDA UDI
Description: Quantia Ferritin Calibrators FDA UDI

Identifiers

Catalog Number: 06K4904 FDA UDI
Primary DI / UDI-DI: 00380740156329 FDA UDI
510(k) Number: K040879 FDA UDI
FDA Product Code: JIT FDA UDI
DBF FDA UDI
JJX FDA UDI
GMDN Term: Ferritin IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
866.5340 FDA UDI
862.1660 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: Ferritin IVD, calibrator

Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ferritin IVD, calibrator.

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Dimension® FERR Calibrator — Siemens Healthcare Diagnostics · Class II
K-ASSAY® Ferritin Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
Alinity — ABBOTT IRELAND · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class I

Cleared under the same submission

K040879 also covers:

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 Laboratories, Inc.

Sources (1)

FDA UDI 7c26f43f-0447-4a75-b9bd-b0850ddb0950 37 fields · synced May 31, 2026