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Dimension Vista® System FPSA Flex® Reagent Cartridge
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Dimension Vista® System FPSA Flex® Reagent Cartridge FDA UDI
- Generic Name
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Free Prostate Specific Antigen Flex® reagent cartridge 80 Test FDA UDI
- Model / Reference
- 10445091 FDA UDI
- Description
- Free Prostate Specific Antigen Flex® reagent cartridge 80 Test FDA UDI
Identifiers
- Catalog Number
- K6452 FDA UDI
- Primary DI / UDI-DI
- 00842768016677 FDA UDI
- PMA Number
- P020027 FDA UDI
- FDA Product Code
- MTG FDA UDI
- GMDN Term
- Free (unbound) prostate specific antigen (fPSA) 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: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Dimension Vista® System FPSA Flex® Reagent Cartridge by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott Ireland Diagnostics · Class III
- Access Hybritech free PSA — Beckman Coulter, Inc. · Class III
- ARCHITECT — Abbott Ireland Diagnostics · Class III
- Access Hybritech p2PSA Calibrators — Beckman Coulter, Inc. · Class III
- Access Hyritech free PSA Calibrators — Beckman Coulter, Inc. · Class III
- IMMULITE®/IMMULITE®1000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Access Hybritech p2PSA — Beckman Coulter, Inc. · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
Cleared under the same submission
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
Sources (1)
- FDA UDI 0510eb5a-af0e-490e-abf6-6f6e9d56d56e 37 fields · synced May 31, 2026