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Sonoclot® Reference Plasma Quality Control Kit
FDA UDIClass II (US FDA UDI)
by Sienco, Inc.
Identity
- Trade Name
- Sonoclot® Reference Plasma Quality Control Kit FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation. Each Kit contains: 1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material. 1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water. 1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride. 5 plastic 1 ml syringes 2 non-activated test cuvettes (blue with clear caps, stir bars, and probes) FDA UDI
- Model / Reference
- 900-1318 FDA UDI
- Description
- The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation. Each Kit contains: 1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material. 1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water. 1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride. 5 plastic 1 ml syringes 2 non-activated test cuvettes (blue with clear caps, stir bars, and probes) FDA UDI
Identifiers
- Catalog Number
- 900-1318 FDA UDI
- Primary DI / UDI-DI
- B55890013181 FDA UDI
- 510(k) Number
- K952560 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control 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, control
Sonoclot® Reference Plasma Quality Control Kit by Sienco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 0d85fdcd-dbd2-4a97-948b-9f55b78bb5d7 37 fields · synced May 30, 2026