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Atellica IM CEA

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM CEA FDA UDI
Generic Name
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
CEA - Atellica IM - RGT 500T FDA UDI
Model / Reference
11206246 FDA UDI
Description
CEA - Atellica IM - RGT 500T FDA UDI

Identifiers

Catalog Number
11206246 FDA UDI
Primary DI / UDI-DI
00630414293585 FDA UDI
510(k) Number
K981478 FDA UDI
FDA Product Code
DHX FDA UDI
GMDN Term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Atellica IM CEA by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K981478 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI f32feeaa-fe99-4779-bdbf-0c86494091d9 37 fields · synced Jun 8, 2026