IMMULITE® 2000 Systems PTS PSA
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- IMMULITE 2000 PSA EUDAMEDIMMULITE® 2000 Systems PTS PSA FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_C_REAG_KIT_PSA EUDAMEDPTS PSA Kit 200 Test FDA UDI
- Model / Reference
- IVDR_67_LLB_DUB-C_C_REAG_KIT_PSA EUDAMED10380996 EUDAMED10706281 FDA UDI
- Description
- PTS PSA Kit 200 Test FDA UDI
Identifiers
- Catalog Number
- L2KPTS2(D) FDA UDI
- Primary DI / UDI-DI
- 00630414961965 EUDAMED00630414982212 FDA UDI
- Basic UDI-DI
- 0405686901460VG EUDAMED
- PMA Number
- P930027 FDA UDI
- FDA Product Code
- MTF 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 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
Yes
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
IMMULITE® 2000 Systems PTS PSA by Siemens Healthcare Diagnostics Products Ltd — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
- Dimension Vista® System TPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics · Class III
- Total PSA AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- Total PSA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- Elecsys tPSA — Roche Diagnostics Corp. · Class III
Cleared under the same submission
P930027 also covers:
- IMMULITE® 2000 Systems PTS PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE®1000 Systems PTS PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®Systems sPS CONTROL Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI 6324ba9d-4c9f-42ca-aac1-6ca6ab46fb11 37 fields · synced Jul 23, 2026
- EUDAMED 5ae9cb18-368a-4d4b-aae9-8ed80e6ce05a 61 fields · synced Jul 23, 2026