Identity
- Trade Name
- ADVIA Centaur EPO Quality Control FDA UDI
- Generic Name
- Erythropoietin (EPO) IVD, control FDA UDI
- Device Name
- Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL FDA UDI
- Model / Reference
- 10995099 FDA UDI
- Description
- Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL FDA UDI
Identifiers
- Catalog Number
- 10995099 FDA UDI
- Primary DI / UDI-DI
- 00630414010403 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
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
Yes
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, control
ADVIA Centaur EPO Quality Control by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Erythropoietin (EPO) IVD, control.
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- Atellica IM EPO QC — Siemens Healthcare Diagnostics · Class I
- Atellica IM EPO MCM — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur EPO MCM — Siemens Healthcare Diagnostics · Class I
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 43976378-872d-4403-b7e5-aa52042ed616 36 fields · synced May 31, 2026