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Assayed Urine Control Device Master File by sharmashyamsingh is a document available to read on EtoBox.

What is Assayed Urine Control Device Master File about?

The document is a Device Master File for Assayed Urine Control, an in vitro diagnostic medical device intended for quality control of diagnostic assays, supplied at two levels with a shelf life of 48 months. It includes marketing history, regulatory approvals, product composition, and manufacturing details, indicating that it falls under Risk Class-B. The Assayed Urine Control is designed to improve laboratory accuracy and reliability, with no reported adverse events over the past five years.

Author

sharmashyamsingh

Language

EN