Alinity m You-CreateTM

For more information, contact Abbott.

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Alinity m laboratory developed test (LDT) feature enables labs to develop assays using Alinity m You-CreateTM accessories and You-Create base application specification files.

Alinity m LDT feature is intended for use by a trained laboratory professional to develop and conduct the real-time PCR-based applications with the Alinity m System which provide quantitative or qualitative detection of nucleic acid sequences for diagnostic purposes.

IMPORTANT:
 Laboratory developed applications are not validated by Abbott and require user validation for the intended uses defined by the application developers.

Alinity m Laboratory Developed Test Operations Manual 09N90-001 (53-608294/R01)