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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Quantia Immunoglobulin E FDA UDI
Model / Reference
06K4241 FDA UDI
Description
Quantia Immunoglobulin E FDA UDI

Identifiers

Catalog Number
06K4241 FDA UDI
Primary DI / UDI-DI
00380740156282 FDA UDI
510(k) Number
K050493 FDA UDI
FDA Product Code
DGC FDA UDI
JJS FDA UDI
JJX FDA UDI
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 FDA UDI
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Allergen-specific immunoglobulin E (IgE) antibody 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 Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K050493 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Laboratories, Inc.

Sources (1)

  • FDA UDI 532bcfd4-8f55-4a8e-92e4-64a9693c34d5 37 fields · synced May 30, 2026