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I' APPROVED OMB: NO.3150-0038 U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 483 (8-91) EXPIRES: 2-29-93 ESTIMATED 10 CFR 31 BURDEN PER RESPONSE TO COMPLY WITH THIS INFORMATION COLLECTION REQUEST: 7

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What is registration certificate for in-vitro?

A registration certificate for in-vitro is a document that certifies the registration of a in-vitro diagnostic (IVD) medical device.

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

Manufacturers, importers, and distributors of in-vitro diagnostic (IVD) 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, you need to provide information about the manufacturer, importer, distributor, device details, intended use, and other relevant details as per the regulatory guidelines.

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

The purpose of a registration certificate for in-vitro is to ensure that the in-vitro diagnostic (IVD) medical devices meet the regulatory requirements and are safe and effective for use.

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

The registration certificate for in-vitro must include information about the manufacturer, importer, distributor, device details, intended use, labeling, clinical performance data, and any other information required by the regulatory authority.

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