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*Approved by 0 MB 3150-0035 1-3184 U.S. NUCLEAR REGULATORY COMMISSION A RC Form 483 1241) 10 CFR 31 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section

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What is registration certificate - in-vitro?

A registration certificate - in-vitro is a document that allows a company to legally distribute in-vitro diagnostic medical devices in a specific market.

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

Companies that manufacture or distribute in-vitro diagnostic medical devices are required to file registration certificate - in-vitro.

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To fill out registration certificate - in-vitro, companies need to provide information about the device, manufacturing process, intended use, and regulatory compliance.

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The purpose of registration certificate - in-vitro is to ensure the safety and effectiveness of in-vitro diagnostic medical devices in the market.

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Information such as device specifications, labeling, quality control procedures, and evidence of compliance with regulatory requirements must be reported on registration certificate - in-vitro.

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