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Form Approved Budge Lt Bureau No. 38-R. O 160 US. ATOMIC ENERGY COMMISSION Form AEC-483 '1/74 10 CFR 31 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section

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What is registration certificate for in-vitro?

The registration certificate for in-vitro is a document that certifies the authorization of a medical device, reagent, or instrument used in diagnostics or testing.

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

Any manufacturer, importer, or distributor of in-vitro medical devices, reagents, or instruments is required to file a registration certificate.

How to fill out registration certificate for in-vitro?

The registration certificate for in-vitro can be filled out by providing relevant information about the medical device, reagent, or instrument, including its intended use, technical specifications, and manufacturing details.

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

The purpose of the registration certificate for in-vitro is to ensure that medical devices, reagents, or instruments used in diagnostics or testing meet the necessary quality and safety standards.

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

The registration certificate for in-vitro requires information such as the device's name, manufacturer details, intended use, technical specifications, manufacturing process, and any relevant documentation or certifications.

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