Identity
- Trade Name
- Sonoclot® kACT Kit FDA UDI
- Generic Name
- Multiple coagulation factor IVD, kit, clotting FDA UDI
- Device Name
- The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. FDA UDI
- Model / Reference
- 800-0400 FDA UDI
- Description
- The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. FDA UDI
Identifiers
- Catalog Number
- 800-0400 FDA UDI
- Primary DI / UDI-DI
- B55880004001 FDA UDI
- 510(k) Number
- K952560 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
Yes
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: Multiple coagulation factor IVD, kit, clotting
Sonoclot® kACT Kit by Sienco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, kit, clotting.
- CRYOcheck™ Clot C™ — Precision Biologic · Class II
- CRYOcheck™ Clot C™ — Precision Biologic · Class II
- ROTEM® — Tem Innovations GmbH · Class II
- Sonoclot® NonActivated Kit — SIENCO, INC. · Class II
- Sonoclot® aiACT Kit — SIENCO, INC. · Class II
- Sonoclot® NonActivated Kit — SIENCO, INC. · Class II
- Sonoclot® gbACT+ Kit — SIENCO, INC. · Class II
- Sonoclot® gbACT+ Kit — SIENCO, INC. · Class II
Cleared under the same submission
K952560 also covers:
- Sonoclot® Coagulation & Platelet Function Analyzer — SIENCO, INC.
- 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.
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 0c6f222f-0326-42e5-88a9-21cea1d47d50 37 fields · synced Jun 8, 2026