ADVIA Centaur® cPSA PRE
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® cPSA EUDAMEDFDA UDIADVIA Centaur® cPSA PRE FDA UDI
- Generic Name
- Complexed prostate specific antigen (cPSA) IVD, reagent FDA UDIComplexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_cPSA EUDAMEDComplexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack FDA UDIComplexed Prostate-specific Antigen (cPSA) Assay Kit 100T FDA UDI
- Model / Reference
- 10310381 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_cPSA EUDAMED10310384 FDA UDI
- Description
- Complexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack FDA UDIComplexed Prostate-specific Antigen (cPSA) Assay Kit 100T FDA UDI
Identifiers
- Catalog Number
- 125308 FDA UDI124830 FDA UDI
- Primary DI / UDI-DI
- 00630414450896 EUDAMEDFDA UDI00630414451558 FDA UDI
- Basic UDI-DI
- 0405686901806VW EUDAMED
- PMA Number
- P990055 FDA UDI
- FDA Product Code
- NAF FDA UDI
- EMDN Code
- W0102030115 COMPLEXED PROSTATIC SPECIFIC ANTIGEN EUDAMED
- GMDN Term
- Complexed prostate specific antigen (cPSA) IVD, reagent FDA UDIComplexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Complexed prostate specific antigen (cPSA) IVD, reagent
ADVIA Centaur® cPSA PRE by Siemens Healthcare Diagnostics — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Complexed prostate specific antigen (cPSA) IVD, reagent.
- Atellica IM cPSA PRE — Siemens Healthcare Diagnostics · Class III
Cleared under the same submission
P990055 also covers:
- ADVIA Centaur® Systems, ACS 180® Systems cPSA MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems cPSA 1, 2, 3 QC — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y — Siemens Healthcare Diagnostics
- Atellica IM Calibrator Y — Siemens Healthcare Diagnostics
- Atellica IM cPSA — Siemens Healthcare Diagnostics
- Atellica IM cPSA MCM — Siemens Healthcare Diagnostics
- Atellica IM cPSA PRE — Siemens Healthcare Diagnostics
- Atellica IM cPSA QC — Siemens Healthcare Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (3)
- FDA UDI 5afced58-07e4-41c9-9b81-4b8087b1d3c7 37 fields · synced Jul 10, 2026
- FDA UDI 15597af2-08c5-41a1-8fb1-6a3d88b9cd34 37 fields · synced May 30, 2026
- EUDAMED 1466a2df-078c-4dd1-8778-e2efe13959db 61 fields · synced Jul 10, 2026