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Sonoclot® SonACT Kit

FDA UDI

Class II (US FDA UDI)

by Sienco, Inc.

Identity

Trade Name
Sonoclot® SonACT Kit FDA UDI
Generic Name
Multiple coagulation factor IVD, kit, clotting FDA UDI
Device Name
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 100 lidded colorless plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar. FDA UDI
Model / Reference
800-0432 FDA UDI
Description
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 100 lidded colorless plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar. FDA UDI

Identifiers

Catalog Number
800-0432 FDA UDI
Primary DI / UDI-DI
B55880004321 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® SonACT 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.

Cleared under the same submission

K952560 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sienco, Inc.

Sources (1)

  • FDA UDI cb2d6cd7-95df-4617-9bb4-212962024a76 37 fields · synced May 30, 2026