Identity
- Trade Name
- Dimension® Flex® reagent cartridge CRP FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- C-Reactive Protein Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10444894 FDA UDI
- Description
- C-Reactive Protein Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- DF37 FDA UDI
- Primary DI / UDI-DI
- 00842768005527 FDA UDI
- 510(k) Number
- K945280 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5270 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimension® Flex® reagent cartridge CRP by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 05e71ce8-16f9-471e-99aa-68ddebf5dfe0 38 fields · synced Jun 8, 2026