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U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 483 (1-95).:: REGISTRATION CERTIFICATE -- in vitro TESTING, WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE APPROVED BY OMB: NO. 3150-0038 EXPIRES 3-31-96
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What is registration certificate for in-vitro?
The registration certificate for in-vitro is a document that allows the sale and distribution of in-vitro diagnostic medical devices within a specific jurisdiction.
Who is required to file registration certificate for in-vitro?
Manufacturers or importers of in-vitro diagnostic medical devices are required to file for a registration certificate.
How to fill out registration certificate for in-vitro?
To fill out the registration certificate for in-vitro, manufacturers or importers need to provide information such as device details, intended use, manufacturing facilities, clinical trial data (if applicable), and quality control measures.
What is the purpose of registration certificate for in-vitro?
The purpose of the registration certificate for in-vitro is to ensure that in-vitro diagnostic medical devices meet regulatory requirements and are safe and effective for use.
What information must be reported on registration certificate for in-vitro?
The registration certificate for in-vitro requires information such as device specifications, intended use, manufacturing details, clinical trial data (if applicable), and quality control measures.
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