ADVIA Centaur® CA 125II MCM

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur® CA 125II MCM FDA UDI
Generic Name: Cancer antigen 125 (CA125) IVD, control FDA UDI
Device Name: CA 125 II Master Curve Material Kit - CENTAUR - CONS FDA UDI
Model / Reference: 10310442 FDA UDI
Description: CA 125 II Master Curve Material Kit - CENTAUR - CONS FDA UDI

Identifiers

Catalog Number: 128530 FDA UDI
Primary DI / UDI-DI: 00630414461274 FDA UDI
510(k) Number: K020828 FDA UDI
FDA Product Code: LTK FDA UDI
GMDN Term: Cancer antigen 125 (CA125) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.6010 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: Cancer antigen 125 (CA125) IVD, control

ADVIA Centaur® CA 125II MCM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cancer antigen 125 (CA125) IVD, control.

Alinity — Abbott · Class I
CA-125 Control Slides — BIO SB, INC. · Class I
IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
CA-125 Control Slides — BIO SB, INC. · Class I
ARCHITECT — Abbott · Class I
CA-125 control slides — BIO SB, INC. · Class I
Atellica IM CA 125II MCM — Siemens Healthcare Diagnostics · Class I

Cleared under the same submission

K020828 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: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI bb605242-88ba-4db7-b14b-e44260b636cc 37 fields · synced May 30, 2026