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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Microalbumin IVD, control FDA UDI
Device Name
Microalbumin Controls FDA UDI
Model / Reference
2K98-10 FDA UDI
Description
Microalbumin Controls FDA UDI

Identifiers

Catalog Number
02K9810 FDA UDI
Primary DI / UDI-DI
00380740003647 FDA UDI
510(k) Number
K030320 FDA UDI
FDA Product Code
JIS FDA UDI
JJX FDA UDI
JIQ FDA UDI
GMDN Term
Microalbumin IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1660 FDA UDI
862.1645 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

No

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: Microalbumin IVD, control

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

Similar devices

Also classified as Microalbumin IVD, control.

Cleared under the same submission

K030320 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 3ab10404-dfcf-4a8b-b4c3-ad6b3c4513e9 37 fields · synced May 30, 2026