Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems.

Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems.
VIDAS® QCV - 30706

A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OHQ

Device Name: Multi-Analyte Controls Unassayed

Device Class: 1

Physical State: quality control material

Definition: A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: quality control material

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: in vitro diagnostic

Regulation Number: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 03573026121631

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A