Clarity Diagnostics Clarity iFOB Controls

The Clarity Diagnostics iFOB Controls are exclusively designed for use with the Clarity Diagnostics iFOB Test Kit, identified by the part number #DTG-FOB01.

These controls are essential for quality assurance and validation procedures:

• They ensure the precision and reliability of the iFOB testing process.
• The package includes both Positive and Negative control reagents.
• The controls are supplied in Factory New condition and intended strictly for In-vitro Diagnostic Use.

For optimal integrity, they must be stored at temperatures between 2°C and 30°C.

No, these controls are not universally compatible. They are engineered exclusively for calibration and validation of the specific Clarity Diagnostics iFOB Test Kit (#DTG-FOB01).

Key details:

• They are a dedicated calibration tool for the Clarity Diagnostics platform.
• Their use ensures the highest reliability and precision for that associated test kit.

They must not be used with iFOB test kits from other manufacturers.

The Clarity iFOB Controls are essential calibration and validation tools designed exclusively for use with the Clarity Diagnostics iFOB Test Kit (Part #DTG-FOB01).

They ensure maximum reliability and accuracy in your diagnostic workflow by providing known standards for quality assurance. This process is critical for maintaining compliance when conducting Fecal Occult Blood testing.

These controls confirm the operational integrity of the test kit through two specific components for In-vitro Diagnostic Use:

• Positive Control: Confirms that the iFOB test kit is working correctly and is reacting within necessary performance parameters.
• Negative Control: Ensures the test maintains specificity and prevents the generation of false positive results.

By successfully running both the positive and negative standards, users fully validate the accuracy and operational integrity of the test kit before analyzing patient samples.

The Manufacturer Part Number (MPN) for the Clarity Diagnostics iFOB Controls is DTG-FOBCTLS. This number is used for tracking and identification of this calibration and validation tool.

The Clarity Diagnostics iFOB Controls package is designed to provide the essential reagents needed for validating and calibrating the associated iFOB Test Kit (#DTG-FOB01).

The box includes the following two critical control vials:

• Positive Control vial (Red Cap): This component is necessary for verifying that the test system is functioning correctly and is capable of detecting a positive result.
• Negative Control vial (White Cap): This ensures the baseline reliability of the test, confirming the absence of non-specific or false-positive results.

Both vials are required for comprehensive quality control and are explicitly labeled for In-vitro Diagnostic Use.

The Clarity iFOB Controls must be stored under specific conditions to maintain their integrity and ensure reliable calibration and validation of the associated iFOB Test Kit.

• Required Storage Temperature: The controls must be stored between 2°C and 30°C.

Proper storage is critical as these materials are essential for quality control and are explicitly labeled For In-vitro Diagnostic Use.

These iFOB controls are manufactured by Clarity Diagnostics.

Yes, the Clarity Diagnostics iFOB Controls are supplied in Factory New condition. This ensures optimal performance and reliability for calibrating and validating the associated Clarity Diagnostics iFOB Test Kit (#DTG-FOB01).

Yes, the Clarity iFOB Controls are specifically designed and exclusively intended for use with the Clarity Diagnostics iFOB Test Kit (#DTG-FOB01).

Their primary function is to serve as essential calibration and validation tools, enhancing the overall reliability and precision of your iFOB testing workflow.

Yes, the Clarity Diagnostics iFOB Controls are intended for in-vitro diagnostic use within professional diagnostic environments, ensuring adherence to rigorous quality control standards.