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IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 3PS Third Generation PSA Kit 100 Test FDA UDI
- Model / Reference
- 10706293 FDA UDI
- Description
- 3PS Third Generation PSA Kit 100 Test FDA UDI
Identifiers
- Catalog Number
- LK3PS1(D) FDA UDI
- Primary DI / UDI-DI
- 00630414982267 FDA UDI
- PMA Number
- P930027 FDA UDI
- FDA Product Code
- MTF FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA by Siemens Healthcare Diagnostics Products Ltd — Class III — FDA UDI — listed in FDA GUDID
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® 2000 Systems PTS 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 (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 III | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI f45d433d-fb8d-4f6f-ab2a-d470dc405717 37 fields · synced May 30, 2026