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7 q U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 483 (4-901 10CFR 31 REGISTRATION CERTIFICATE-in Vito TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE q APPROVED NO. 3150×0038 EXPIRES. 2-29-93
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What is registration certificate for in-vitro?
A registration certificate for in-vitro is a document that proves the registration of an in-vitro diagnostic medical device for commercial use.
Who is required to file registration certificate for in-vitro?
Manufacturers, importers, or distributors of in-vitro diagnostic medical devices are required to file a registration certificate.
How to fill out registration certificate for in-vitro?
To fill out a registration certificate for in-vitro, one needs to provide information about the device, such as its name, intended use, manufacturer details, and technical specifications.
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 medical device meets the necessary regulatory requirements and is safe for use.
What information must be reported on registration certificate for in-vitro?
The registration certificate for in-vitro must include information about the device's name, intended use, classification, manufacturer details, technical specifications, and any supporting documentation.
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