ADVIA Centaur® T4 DIL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur® T4 DIL FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: T4 Diluent - CENTAUR - CAL - 1x10mL FDA UDI
Model / Reference: 10311585 FDA UDI
Description: T4 Diluent - CENTAUR - CAL - 1x10mL FDA UDI

Identifiers

Catalog Number: 672202000 FDA UDI
Primary DI / UDI-DI: 00630414125121 FDA UDI
510(k) Number: K905532 FDA UDI
FDA Product Code: CDX FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1700 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

ADVIA Centaur® T4 DIL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ARCHITECT — Abbott Laboratories, Inc. · Class II
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Cleared under the same submission

K905532 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 8c4b529f-93b9-4f34-ad27-a1a7c8f617bc 37 fields · synced May 30, 2026