Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Plasma protein IVD, control FDA UDI
Device Name: Quantia PROTEINS Control FDA UDI
Model / Reference: 6K53-21 FDA UDI
Description: Quantia PROTEINS Control FDA UDI

Identifiers

Catalog Number: 06K5321 FDA UDI
Primary DI / UDI-DI: 00380740044862 FDA UDI
510(k) Number: K050596 FDA UDI
K050613 FDA UDI
FDA Product Code: JJX FDA UDI
JJS FDA UDI
DEM FDA UDI
GMDN Term: Plasma protein IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
866.5130 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: Plasma protein IVD, control

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

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Cleared under the same submission

K050596 also covers:

K050613 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

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Manufacturer

Manufacturer: Abbott Laboratories, Inc.

Sources (1)

FDA UDI 5404c447-7c29-455c-b3c3-26378e6586de 37 fields · synced May 31, 2026