Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Ferritin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name: Quantia Ferritin FDA UDI
Model / Reference: 6K41-50 FDA UDI
Description: Quantia Ferritin FDA UDI

Identifiers

Catalog Number: 06K4150 FDA UDI
Primary DI / UDI-DI: 00380740057718 FDA UDI
510(k) Number: K040879 FDA UDI
FDA Product Code: DBF FDA UDI
JJX FDA UDI
JIT FDA UDI
GMDN Term: Ferritin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5340 FDA UDI
862.1660 FDA UDI
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

Yes

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, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Ferritin IVD, kit, nephelometry/turbidimetry.

N Latex Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
ADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics · Class II
Yumizen C1200 Ferritin — Horiba Abx · Class II
Tina-quant Ferritin Gen.4 — Roche Diagnostics Corp. · Class II
ADVIA® Chemistry FRT Ferritin Reagents — Siemens Healthcare Diagnostics · Class II
Diazyme — Diazyme Laboratories, Inc.
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 51f13480-727c-4fb9-bb68-8ee7b5d66504 37 fields · synced Jun 8, 2026