Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Microalbumin IVD, calibrator FDA UDI
Device Name: Microalbumin Calibrators FDA UDI
Model / Reference: 2K98-02 FDA UDI
Description: Microalbumin Calibrators FDA UDI

Identifiers

Catalog Number: 02K9802 FDA UDI
Primary DI / UDI-DI: 00380740003630 FDA UDI
510(k) Number: K030320 FDA UDI
FDA Product Code: JIS FDA UDI
JIQ FDA UDI
JJX FDA UDI
GMDN Term: Microalbumin IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
862.1645 FDA UDI
862.1660 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: Microalbumin IVD, calibrator

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

Similar devices

Also classified as Microalbumin IVD, calibrator.

ARCHITECT — ABBOTT IRELAND · Class II
ARCHITECT — Abbott · Class I
Autokit Micro Albumin Calibrator Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
Atellica CH µALB_2 Calibrator — Siemens Healthcare Diagnostics · Class II
Pointe Scientific, Inc. Microalbumin Calibrator — POINTE SCIENTIFIC, INC. · Class II
Chemistry UALB Calibrator Kit — Medica Corp. · Class II
Dimension® MALB Calibrator — Siemens Healthcare Diagnostics · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II

Cleared under the same submission

K030320 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 22f79f89-8391-4733-9e2e-96ab84502c9b 37 fields · synced May 30, 2026