The following products are currently registered and cleared for clinical use under the CE Mark. Please contact Sienco if you are unsure of your country's regulatory requirements. For products currently cleared for clinical use under the U.S. FDA, please visit our Sonoclot USA site.
Quality control kits are available for both the analyzers and disposable tests. Each kit contains supplies for one month's worth of quality control testing.
Sienco recommends that quality control testing should be performed on the analyzer each day prior to use. Quality control testing of disposable tests should be preformed once a month and on each new lot received. Additional testing may be required to meet your institution's specific requirements.
REFERENCE VISCOSITY OIL QUALITY CONTROL KITS:
Kits contain 24 tests/channel for verifying instrument response. Includes Oil QC Fluid, Cuvettes and Probes. Use this to verify correct performance of the Sonoclot Analyzer.
900-1303 SC1/SCP1 Reference Viscosity Oil QC Kit
900-1324 SCP2 Reference Viscosity Oil QC Kit
900-1343 SCP4 Reference Viscosity Oil QC Kit
900-1318 REFERENCE PLASMA QUALITY CONTROL KIT
Includes one set of normal and abnormal controls, necessary reagents, and syringes for use. Use this test to verify correct performance of activated tests. This test should be run on new product shipments of activated tests prior to clinical use and monthly throughout the use of the activated test inventory.