ADVIA® Chemistry Microalbumin_2 Calibrators

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA® Chemistry Microalbumin_2 Calibrators FDA UDI
Generic Name: Microalbumin IVD, calibrator FDA UDI
Device Name: Microalbumin - ADVIA Chem. - CAL - 5x2mL FDA UDI
Model / Reference: 10337470 FDA UDI
Description: Microalbumin - ADVIA Chem. - CAL - 5x2mL FDA UDI

Identifiers

Catalog Number: 6487733 FDA UDI
Primary DI / UDI-DI: 00630414534077 FDA UDI
510(k) Number: K072204 FDA UDI
FDA Product Code: JIX FDA UDI
GMDN Term: Microalbumin IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

ADVIA® Chemistry Microalbumin_2 Calibrators by Siemens Healthcare Diagnostics — 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
ARCHITECT — Abbott Laboratories, Inc. · Class II
Pointe Scientific, Inc. Microalbumin Calibrator — POINTE SCIENTIFIC, INC. · Class II
Chemistry UALB Calibrator Kit — Medica Corp. · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
VITROS — Ortho-Clinical Diagnostics · Class II

Cleared under the same submission

K072204 also covers:

Atellica CH µALB_2 Calibrator — Siemens Healthcare Diagnostics

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: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 8773b7ff-e635-43c1-9602-eea31abb009f 37 fields · synced May 30, 2026