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Approved by OMS' 3150-003S 1-31487 U.S. NUCLEAR REGULATORY COMMISSION 433,.pro 112-81) 10 CFR31 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE 111 of 10 CMR
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What is registration certificate for in-vitro?
A registration certificate for in-vitro is a document that certifies the registration and approval of in-vitro diagnostic medical devices.
Who is required to file registration certificate for in-vitro?
Manufacturers, importers, and 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, the required information such as device details, intended use, manufacturing information, and conformity assessment should be provided accurately.
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 in compliance with regulatory requirements.
What information must be reported on registration certificate for in-vitro?
The registration certificate for in-vitro should include information such as device identification, product specifications, intended use, manufacturing details, and conformity assessment.
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