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Sonoclot® NonActivated Kit

FDA UDI

Class II (US FDA UDI)

by Sienco, Inc.

Identity

Trade Name
Sonoclot® NonActivated Kit FDA UDI
Generic Name
Multiple coagulation factor IVD, kit, clotting FDA UDI
Device Name
The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated 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 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar. FDA UDI
Model / Reference
800-0426 FDA UDI
Description
The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated 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 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar. FDA UDI

Identifiers

Catalog Number
800-0426 FDA UDI
Primary DI / UDI-DI
B55880004261 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple coagulation factor IVD, kit, clotting

Sonoclot® NonActivated 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 638534ac-4a42-414e-b1c4-5201f6bc5316 37 fields · synced May 31, 2026