Atellica IM CEA DIL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Atellica IM CEA DIL FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: CEA Diluent Atellica IM - CONS - (2PK) 2 x 5mL FDA UDI
Model / Reference: 10995525 FDA UDI
Description: CEA Diluent Atellica IM - CONS - (2PK) 2 x 5mL FDA UDI

Identifiers

Catalog Number: 10995525 FDA UDI
Primary DI / UDI-DI: 00630414598529 FDA UDI
510(k) Number: K981478 FDA UDI
FDA Product Code: DHX FDA UDI
GMDN Term: Buffered sample diluent IVD 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: Buffered sample diluent IVD

Atellica IM CEA DIL by Siemens Healthcare Diagnostics — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 5ea8a043-9b29-4fce-aaa1-101a11ee0298 37 fields · synced Jun 8, 2026