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Approved by GAO U.S. NUCLEAR REGULATORY COMMISSION NRC Form 483 1-76 3-O6 38-R0160 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE 10 CFR 31 Section 31.11 of
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What is registration certificate for in-vitro?
The registration certificate for in-vitro is a document that proves the compliance of in-vitro diagnostic medical devices with the applicable regulatory requirements.
Who is required to file registration certificate for in-vitro?
Manufacturers, importers, and 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?
To fill out the registration certificate for in-vitro, you need to provide information such as the device's identification details, intended use, technical specifications, clinical data, labeling information, and details of the manufacturer or supplier.
What is the purpose of registration certificate for in-vitro?
The purpose of the registration certificate for in-vitro is to ensure the safety, quality, and performance of in-vitro diagnostic medical devices in accordance with the regulatory requirements.
What information must be reported on registration certificate for in-vitro?
The registration certificate for in-vitro must include information such as the device's identification details, intended use, technical specifications, clinical data, labeling information, and details of the manufacturer or supplier.
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