Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Beta-2-microglobulin IVD, calibrator FDA UDI
Device Name: Quantia B2-Microglobulin Calibrator FDA UDI
Model / Reference: 06K4704 FDA UDI
Description: Quantia B2-Microglobulin Calibrator FDA UDI

Identifiers

Catalog Number: 06K4704 FDA UDI
Primary DI / UDI-DI: 00380740156312 FDA UDI
510(k) Number: K050613 FDA UDI
FDA Product Code: JJX FDA UDI
JJS FDA UDI
JZG FDA UDI
GMDN Term: Beta-2-microglobulin IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
866.5630 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: Beta-2-microglobulin IVD, calibrator

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

Similar devices

Also classified as Beta-2-microglobulin IVD, calibrator.

Atellica CH B2M Calibrator — Siemens Healthcare Diagnostics · Class II
K-ASSAY® Beta-2 Microglobulin Urine Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) — Randox Laboratories, Ltd. · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class I
Alinity — Abbott Laboratories, Inc. · Class II

Cleared under the same submission

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 4e2da0f8-f2e2-4604-aa03-3e4e20b2e7d9 37 fields · synced May 31, 2026