What Is Required for Incorporating an FDA-Approved Test into a Laboratory

question 26

Multiple Choice

What is required for incorporating an FDA-approved test into a laboratory?

• A) Proceed to use the test reagents according to the manufacturer's directions.
• B) Validate test performance on reference and validation specimens.
• C) Use the test, substituting reagents previously validated in the laboratory.
• D) Request and review quality-assurance data from the manufacturer.

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Definitions:

Troubleshooting

The process of diagnosing the source of a problem in a system or machine and determining how to solve it.

Faulty Operation

Performance of a machine, process, or system that deviates from normal or expected functioning due to errors or defects.

RSWho Function

A diagnostic tool in Rockwell Automation software used to browse and identify devices on a network.

Allen-Bradley Controllers

Industrial automation controllers, including PLCs and PACs, manufactured by Rockwell Automation, used for various automation tasks.