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ADVIA Centaur EPO

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur EPO FDA UDI
Generic Name
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T FDA UDI
Model / Reference
10995096 FDA UDI
Description
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T FDA UDI

Identifiers

Catalog Number
10995096 FDA UDI
Primary DI / UDI-DI
00630414010380 FDA UDI
510(k) Number
K183088 FDA UDI
FDA Product Code
GGT FDA UDI
GMDN Term
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7250 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

Yes

FDA UDI

Category: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K183088 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 781372f5-1975-4742-908f-cf11526aa298 37 fields · synced Jun 8, 2026