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Description

iLine MicroSystems . Chip Specifications: High sensitivity human recombinant thromboplastin, On-board QC (QC Channel), Lot calibration integrated into Chip: Datamatrix, Packed individually, 15 months expiry date at RT (36-77 degrees F), 15 min stability once opened at room temperature, Exclusive reference for USA: intended to be used exclusively in FDA cleared Meters.

Frequently asked questions

Does this chip offer a long room temperature shelf life?

Yes, the iLine Microsystems microINR Chips are designed for excellent stability, ensuring convenient storage and usage:

  • Unopened Shelf Life: They maintain a long expiry date of 15 months when stored at the recommended room temperature range (36°F to 77°F).
  • Stability Once Opened: Since the chips are individually packed, once a single foil-sealed pouch is opened, the chip maintains operational stability for 15 minutes at room temperature.
How long is the chip stable after opening?

The microINR Chip remains stable for 15 minutes once the packaging is opened. It is crucial that the chip is used promptly within this window and kept at room temperature (36°F to 77°F) to ensure measurement accuracy and reliability.

Is this chip designed for FDA-cleared meters?

Yes, the iLine Microsystems Micro INR Chip is designed for use exclusively with FDA-cleared meters within the USA. This specific formulation serves as an exclusive reference for the US market, ensuring proper regulatory compliance and reliable INR testing performance.

How is accuracy ensured with this chip?

The accuracy of the microINR Chip is ensured through multiple integrated features designed for reliable coagulation testing:

  • High Sensitivity Reagent: It utilizes high sensitivity human recombinant thromboplastin for precise International Normalized Ratio (INR) measurements.
  • Integrated Quality Control (QC): The chip includes an On-board QC (QC Channel) for immediate verification of the test components and process reliability.
  • Automated Calibration: Lot calibration data is integrated directly onto the chip via a Datamatrix, ensuring seamless traceability and precision without manual input.
Can I trust the results with built-in quality checks?

Absolutely. Each chip is designed to meet rigorous standards through:

  • On-board QC channel: Performs automated quality control checks during the test.
  • Datamatrix calibration: Uses advanced technology to ensure seamless and precise lot-specific calibration for every individual test.
Is high-sensitivity human recombinant thromboplastin used?

Yes, the iLine MicroSystems Micro INR Chip utilizes high-sensitivity human recombinant thromboplastin. This feature is essential for ensuring precise and reliable INR measurements.

Is lot calibration integrated into the chip?

Yes, lot calibration is integrated directly into the chip using a Datamatrix. This feature helps ensure the consistency and reliability of your INR measurements.

Are the microINR Chips individually packaged?

Yes, the microINR Chips are individually packaged within the box (25 chips per box).

This individual packaging is crucial as it helps maintain the integrity and stability of the high-sensitivity human recombinant thromboplastin reagent until the moment of testing.

Does the chip ensure reliability across clinical workflows?

Yes, the system is engineered for professional reliability by utilizing high-sensitivity human recombinant thromboplastin. This ensures consistent and accurate coagulation readings, which are vital for patient monitoring.

Is the chip convenient for busy diagnostic settings?

Yes, the chip is designed for efficiency in clinical environments:

  • Flexible storage: Maintains a 15-month shelf life at room temperature (36-77°F), reducing the need for specialized cooling.
  • Individually wrapped: Each chip is sealed in a metallic-finish foil sachet to preserve integrity, offering 15-minute stability once opened for immediate use.