Keyword Analysis & Research: laboratory developed tests

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Who regulates laboratory developed tests?

The EU legislator is regulating laboratory developed tests for the first time with EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices. As a result, its requirements apply directly to laboratories that offer tests they developed themselves. Most of these requirements are not new, but the additional requirements mean that you, as a ...

Why nalfia tests should be used by every testing lab?

Why NALFIA tests should be used by every testing lab Abingdon Health believes that NALFIA tests (nucleic acid lateral flow immunoassays) are the perfect solution for laboratories when it comes to detecting the successful amplification of target DNA sequences.

What do laboratory tests mean?

What is a laboratory test? A laboratory (lab) test is a procedure in which a health care provider takes a sample of your blood, urine, other bodily fluid, or body tissue to get information about your health. Some lab tests are used to help diagnose, screen, or monitor a specific disease or condition.

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