Identity
- Trade Name
- Stratus® CS Acute Care™ DDMR TestPak FDA UDI
- Generic Name
- D-dimer IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer. FDA UDI
- Model / Reference
- 10701511 FDA UDI
- Description
- The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer. FDA UDI
Identifiers
- Catalog Number
- CDDMRE FDA UDI
- Primary DI / UDI-DI
- 00630414986166 FDA UDI
- 510(k) Number
- K110303 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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: D-dimer IVD, kit, fluorescent immunoassay
Stratus® CS Acute Care™ DDMR TestPak by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f2ff958e-fa78-42d9-bb18-18022f4a9991 37 fields · synced Jun 1, 2026