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NRC Form 483 176 10 CFR 31 U.S. NUCLEAR REGULATORY COMMISSION Approved by GAO 3O6 REGISTRATION CERTIFICATE IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE 38R0160 Section 31.1i of 10

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What is registration certificate for in-vitro?

The registration certificate for in-vitro is a document that verifies the registration of in-vitro diagnostic medical devices.

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

Manufacturers or distributors 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 online on the designated portal with the required information and supporting documents.

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

The purpose of the registration certificate for in-vitro is to ensure the safety and efficacy of in-vitro diagnostic medical devices 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 device name, manufacturer details, device classification, intended use, and performance data.

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