Dimension CardioPhase high sensitivity CRP Flex reagent cartridge
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dimension CardioPhase high sensitivity CRP Flex reagent cartridge EUDAMEDFDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_C_REAG_CCRP EUDAMEDCardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10444897 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_C_REAG_CCRP EUDAMED
- Description
- CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- RF434 FDA UDI
- Primary DI / UDI-DI
- 00842768016028 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901077VD EUDAMED
- Unit of Use DI
- 00630414003887 EUDAMED
- 510(k) Number
- K053109 FDA UDI
- FDA Product Code
- NQD FDA UDI
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
- GMDN Term
- C-reactive protein (CRP) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5270 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
Yes
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: C-reactive protein (CRP) IVD, kit, spectrophotometry
Dimension CardioPhase high sensitivity CRP Flex reagent cartridge by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 90cd62e7-0524-449a-9917-34cd0909cba3 37 fields · synced Jul 18, 2026
- EUDAMED 1a49c950-9f60-4805-ae2a-24a9ae166345 61 fields · synced Jul 18, 2026