ADVIA Centaur EPO MCM

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur EPO MCM FDA UDI
Generic Name: Erythropoietin (EPO) IVD, control FDA UDI
Device Name: Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL FDA UDI
Model / Reference: 10995098 FDA UDI
Description: Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL FDA UDI

Identifiers

Catalog Number: 10995098 FDA UDI
Primary DI / UDI-DI: 00630414010397 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Erythropoietin (EPO) IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Erythropoietin (EPO) IVD, control

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

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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 I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI bbe2a59a-646c-48da-8e31-48be52fe4c2f 36 fields · synced May 31, 2026