Identity
- Trade Name
- Xprecia Stride™ Coagulation Analyzer FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, battery-powered FDA UDI
- Device Name
- The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin. FDA UDI
- Model / Reference
- 11065584 FDA UDI
- Description
- The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin. FDA UDI
Identifiers
- Catalog Number
- 11065584 FDA UDI
- Primary DI / UDI-DI
- 00630414025148 FDA UDI
- FDA Product Code
- GGN FDA UDIGJS FDA UDI
- GMDN Term
- Coagulation analyser IVD, point-of-care, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI864.7750 FDA UDI
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coagulation analyser IVD, point-of-care, battery-powered
Xprecia Stride™ Coagulation Analyzer by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coagulation analyser IVD, point-of-care, battery-powered.
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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 e6da5bc3-47c8-4e7b-944e-4b32693fa629 36 fields · synced May 30, 2026