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Form &EC4U (“a4)local. S. ATOMIC ENERGY Commissioner Approved Budget Bureau No. 38RB160REGISTRATION CERTIFICATE IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE31Section 31.11 of 10

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What is registration certificate for in-vitro?

The registration certificate for in-vitro is a document that provides authorization to market and use in-vitro diagnostic medical devices.

Who is required to file registration certificate for in-vitro?

Manufacturers or distributors of in-vitro diagnostic medical devices are required to file the registration certificate.

How to fill out registration certificate for in-vitro?

The registration certificate for in-vitro can be filled out online through the designated regulatory authority's portal with the required information.

What is the purpose of registration certificate for in-vitro?

The purpose of the registration certificate for in-vitro is to ensure that in-vitro diagnostic medical devices meet regulatory standards for safety and effectiveness before being marketed and used.

What information must be reported on registration certificate for in-vitro?

The registration certificate for in-vitro must include details about the manufacturer, device specifications, intended use, performance data, and quality control measures.

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