ADVIA Centaur® CEA MCM

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur® CEA MCM FDA UDI
Generic Name: Carcinoembryonic antigen (CEA) IVD, control FDA UDI
Device Name: CEA Master Curve Material Set - CENTAUR - CONS FDA UDI
Model / Reference: 10311624 FDA UDI
Description: CEA Master Curve Material Set - CENTAUR - CONS FDA UDI

Identifiers

Catalog Number: 672427000 FDA UDI
Primary DI / UDI-DI: 00630414126302 FDA UDI
510(k) Number: K981478 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Carcinoembryonic antigen (CEA) IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

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: Carcinoembryonic antigen (CEA) IVD, control

ADVIA Centaur® CEA MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K981478 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: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 2e9b32db-ce68-436a-94b4-8ae06b5907d2 37 fields · synced May 30, 2026