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I.II U.d. NUCLEAR REGULATORY COMMISSION NRC Form 483 (12-81) 10 CFR 31 Approved by OMB 3150435 REGISTRATION Certificate VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE 14114 Section 31.11
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What is registration certificate for in-vitro?
A registration certificate for in-vitro is a document that grants permission to manufacture or market in-vitro diagnostic medical devices.
Who is required to file registration certificate for in-vitro?
Manufacturers or marketers 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, you need to provide detailed information about the manufacturer, the device, its intended use, and the testing methods.
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 necessary quality and safety standards before they can be marketed or used.
What information must be reported on registration certificate for in-vitro?
The registration certificate for in-vitro must include information such as the product's name, intended use, components, packaging, labeling, and manufacturing process.
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