← Back to catalogue
Sonoclot® Reference Viscosity Oil Quality Control Kit
FDA UDIClass II (US FDA UDI)
by Sienco, Inc.
Identity
- Trade Name
- Sonoclot® Reference Viscosity Oil Quality Control Kit FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer. FDA UDI
- Model / Reference
- 900-1302 FDA UDI
- Description
- The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer. FDA UDI
Identifiers
- Catalog Number
- 900-1302 FDA UDI
- Primary DI / UDI-DI
- B55890013021 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 Viscosity Oil Quality Control 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, control.
- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Coagulation S.A.R.P (Specialty Assayed Reference Plasma) — Helena Laboratories, Corp. · Class II
- Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
- JAS Diagnostics — Drew Scientific , Ltd.
- CueSee® Coag — Eurotrol B.V. · Class II
- COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
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® 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sienco, Inc.
Sources (1)
- FDA UDI 968ecf46-feee-4a55-918e-fb3c49c65ad9 37 fields · synced Jun 8, 2026