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Approved by OMB 31500035 13187U. S. NUCLEAR REGULATORY COMMISSION NRC Form 483 11281) 10 CFR 31REGISTRATION CERTIFICATE IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSESection 31.11 of

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Obtain the registration form for in-vitro from the relevant authority.

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Who needs registration certificate for in-vitro?

01

Individuals or organizations involved in the research, testing, or production of in-vitro diagnostic products may need a registration certificate for in-vitro.

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What is registration certificate for in-vitro?

Registration certificate for in-vitro is a document that allows the manufacturer to legally sell their in-vitro diagnostic medical devices in a specific market.

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

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

How to fill out registration certificate for in-vitro?

The registration certificate for in-vitro can be filled out by providing all required information about the manufacturer, the device, and the intended use of the device.

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

The purpose of the registration certificate for in-vitro is to ensure that the in-vitro diagnostic medical devices meet the necessary quality and safety standards before being sold in the market.

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

Information such as the manufacturer's details, device specifications, intended use, and proof of compliance with relevant regulations must be reported on the registration certificate for in-vitro.

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