Identity
- Trade Name
- Atellica IM PSA FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T FDA UDI
- Model / Reference
- 10995663 FDA UDI
- Description
- Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T FDA UDI
Identifiers
- Catalog Number
- 10995663 FDA UDI
- Primary DI / UDI-DI
- 00630414599816 FDA UDI
- PMA Number
- P950021 FDA UDI
- FDA Product Code
- LTJ FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
No
FDA UDI
Category: Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Atellica IM PSA by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — 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® PSA — Siemens Healthcare Diagnostics
- 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 MCM — Siemens Healthcare Diagnostics
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2adda0ac-48c1-45c5-9e3c-1308984415aa 37 fields · synced May 30, 2026