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ADVIA Centaur® H2n

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® H2n FDA UDI
Generic Name
Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
HER-2/neu - CENTAUR - RGT - 50 tests FDA UDI
Model / Reference
10308994 FDA UDI
Description
HER-2/neu - CENTAUR - RGT - 50 tests FDA UDI

Identifiers

Catalog Number
915031 FDA UDI
Primary DI / UDI-DI
00630414471235 FDA UDI
510(k) Number
K024017 FDA UDI
FDA Product Code
NCW FDA UDI
GMDN Term
Human epidermal growth factor receptor 2 (HER2) protein 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: Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® H2n by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K024017 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 ed16d0f1-734f-4085-874c-e9b1cebd617a 37 fields · synced May 30, 2026