Architect

FDA UDI

Class I (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: 06K4151 FDA UDI
Description: Quantia Ferritin FDA UDI

Identifiers

Catalog Number: 06K4151 FDA UDI
Primary DI / UDI-DI: 00380740156275 FDA UDI
510(k) Number: K040879 FDA UDI
FDA Product Code: JJX FDA UDI
JIT FDA UDI
DBF FDA UDI
GMDN Term: Ferritin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1150 FDA UDI
866.5340 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 I — 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 II

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Abbott Laboratories, Inc.

Sources (1)

FDA UDI b799f846-87ee-4eaa-aa46-f7e78c5baa03 37 fields · synced May 30, 2026