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Elecsys CEA Assay

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys CEA Assay FDA UDI
Generic Name
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
4491777160 FDA UDI

Identifiers

Catalog Number
4491777160 FDA UDI
Primary DI / UDI-DI
04015630938919 FDA UDI
510(k) Number
K980887 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Elecsys CEA Assay by Roche Diagnostics Corp. — 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

K980887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI f8d39c4e-a3e3-477d-9368-0080ec69c7e2 35 fields · synced May 30, 2026