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ADDRESS CHANGE NRC Form 483 1-76 10 CFR 31 U.S. NUCLEAR REGULATORY COMMISSION, ; Approved by GAO 38R0160 i':, REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL-UNDER GENERAL LICENSE:,-
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What is registration certificate for in-vitro?
Registration certificate for in-vitro is a document that confirms the authorization and approval of an in-vitro diagnostic medical device by the relevant regulatory authority.
Who is required to file registration certificate for in-vitro?
Manufacturers, importers, and distributors of in-vitro diagnostic medical devices are required to file registration certificates for in-vitro.
How to fill out registration certificate for in-vitro?
To fill out a registration certificate for in-vitro, the applicant must provide detailed information about the medical device, including its specifications, intended use, manufacturing details, and any relevant certifications or test reports.
What is the purpose of registration certificate for in-vitro?
The purpose of a registration certificate for in-vitro is to ensure the safety, quality, and efficacy of in-vitro diagnostic medical devices. It allows regulatory authorities to track and monitor the distribution and use of these devices.
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 name, model, intended use, manufacturing details, technical specifications, and any relevant certifications or test reports.
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