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Dimension® clinical chemistry system TPSA Flex® reagent cartridge
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Dimension® clinical chemistry system TPSA Flex® reagent cartridge FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test FDA UDI
- Model / Reference
- 10444889 FDA UDI
- Description
- Heterogeneous Immunoassay Module Total Prostate Specific Antigen Flex® reagent cartridge 120 Test FDA UDI
Identifiers
- Catalog Number
- RF451 FDA UDI
- Primary DI / UDI-DI
- 00842768013874 FDA UDI
- PMA Number
- P000021 FDA UDI
- FDA Product Code
- MTF FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)
Dimension® clinical chemistry system TPSA Flex® reagent cartridge by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA).
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- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
Cleared under the same submission
P000021 also covers:
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 eaf81e21-3e8e-455f-b709-738d6f713875 37 fields · synced May 30, 2026