Identity
- Trade Name
- Sonoclot® aiACT Kit FDA UDI
- Generic Name
- Multiple coagulation factor IVD, kit, clotting FDA UDI
- Device Name
- The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. FDA UDI
- Model / Reference
- 800-0442 FDA UDI
- Description
- The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. FDA UDI
Identifiers
- Catalog Number
- 800-0442 FDA UDI
- Primary DI / UDI-DI
- B55880004421 FDA UDI
- 510(k) Number
- K032952 FDA UDI
- FDA Product Code
- JBP FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, kit, clotting 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
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® aiACT Kit by Sienco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple coagulation factor IVD, kit, clotting.
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- 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
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 f1e7196b-d610-4232-8b6d-cf7d3587c92b 37 fields · synced May 30, 2026