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Sonoclot® Coagulation & Platelet Function Analyzer
FDA UDIClass II (US FDA UDI)
by Sienco, Inc.
Identity
- Trade Name
- Sonoclot® Coagulation & Platelet Function Analyzer FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications. FDA UDI
- Model / Reference
- DP-2951 FDA UDI
- Description
- The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B558DP29510 FDA UDI
- FDA Product Code
- JBP FDA UDI
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7140 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
No
FDA UDI
Category: Coagulation analyser IVD, point-of-care, line-powered
Sonoclot® Coagulation & Platelet Function Analyzer by Sienco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, point-of-care, line-powered.
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- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Cleared under the same submission
K952560 also covers:
- Sonoclot® NonActivated Kit — SIENCO, INC.
- Sonoclot® NonActivated Kit — SIENCO, INC.
- Sonoclot® Reference Plasma Quality Control Kit — SIENCO, INC.
- Sonoclot® Reference Viscosity Oil Quality Control Kit — SIENCO, INC.
- Sonoclot® SonACT Kit — SIENCO, INC.
- Sonoclot® kACT Kit — SIENCO, INC.
- Sonoclot® kACT Kit — SIENCO, INC.
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
- Sienco, Inc.
Sources (1)
- FDA UDI c8707be0-417c-4fef-84fd-32c712eb4f76 35 fields · synced Jun 8, 2026