ADVIA Centaur® PSA
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® PSA EUDAMEDFDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_Prostate-Specific Antigen EUDAMEDProstate-specific Antigen (PSA) Assay Kit (5-pack) 500T FDA UDIProstate-specific Antigen (PSA) Assay Kit (1-pack) 100T FDA UDI
- Model / Reference
- 10310292 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_Prostate-Specific Antigen EUDAMED10310293 FDA UDI
- Description
- Prostate-specific Antigen (PSA) Assay Kit (5-pack) 500T FDA UDIProstate-specific Antigen (PSA) Assay Kit (1-pack) 100T FDA UDI
Identifiers
- Catalog Number
- 118157 FDA UDI118156 FDA UDI
- Primary DI / UDI-DI
- 00630414203003 EUDAMEDFDA UDI00630414202990 FDA UDI
- Basic UDI-DI
- 0405686901820VQ EUDAMED
- PMA Number
- P950021 FDA UDI
- FDA Product Code
- LTJ FDA UDI
- EMDN Code
- W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6010 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: Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® PSA by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay.
- Elecsys total PSA — Roche Diagnostics Corp. · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
- Elecsys total PSA — Roche Diagnostics Corp. · Class III
- FastPack® IP Total PSA Kit (90) — QUALIGEN INC. · Class II
- Total PSA AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- Total PSA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Elecsys tPSA — Roche Diagnostics Corp. · Class III
Cleared under the same submission
P950021 also covers:
- ADVIA Centaur® Systems, ACS 180® Systems PSA MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
- Atellica IM PSA MCM — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (3)
- FDA UDI 93e6f003-0486-4d1d-a15c-290e994e9e46 37 fields · synced Jul 9, 2026
- FDA UDI 1022259f-e7c3-4e17-822e-da0c2d1e4c5f 37 fields · synced May 30, 2026
- EUDAMED 97b54473-c772-4933-8f8b-b66b43aa05cd 61 fields · synced Jul 9, 2026