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&-n-nved U.S. NUCLEAR REGt4LATORY COMM1I51UN NRC Form 483 1-76 10CFR 31 HY GAO — 38.-R0160 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section 31.11 of

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What is registration certificate for in-vitro?

The registration certificate for in-vitro is a document that allows manufacturers and distributors to legally sell in-vitro diagnostic medical devices in a particular country or region.

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

Manufacturers and distributors of in-vitro diagnostic medical devices are required to file a registration certificate for in-vitro.

How to fill out registration certificate for in-vitro?

To fill out a registration certificate for in-vitro, manufacturers and distributors must provide information such as the name and address of the company, details about the device, its intended use, and supporting documentation like technical specifications and clinical data.

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

The purpose of a registration certificate for in-vitro is to ensure that in-vitro diagnostic medical devices meet certain quality, safety, and performance standards before they can be sold in the market.

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

The registration certificate for in-vitro must include information such as the device's intended use, its classification, technical specifications, clinical data, manufacturing and distribution details, and any relevant certifications or licenses.

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