Laboratory sampling kit BioSci™ Inactivated Transport Medium

nasopharyngealnasalpharyngeal

Biosci™ Inactivated Transport Medium-510(K): K220059 A. Intended Use Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, inactivation, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays. B. Product Description Specimen collection and transportation is a key part of molecular detection and the stabilization of influenza A (also referred to as Flu A) virus RNA. Biosci™ Inactivated Transport Medium is provided in two different formats – in tube or in kit. The format in kit is supplied in customer convenient pre-packaged collection sets for routine procedures in the diagnosis of infections caused by Flu A virus. Each set comprises of a package containing peel pouch incorporating one specimen collection swab for the collection and one labeled screw-cap tube pre-filled with Biosci™ ITM for safe transportation of biological specimen, and one specimen bag for preventing leakage of biological samples. The format in tube only contains labeled screw-cap tubes pre-filled with Biosci™ ITM. There is no difference between the transport medium contained in the two formats of product. C. Main Compositions 1. Inactivated Transport Medium The Inactivated Transport Medium is provided in a one screw-cap tube, with different configurations of 1, 2, or 3mL. 2. Swab Nasopharyngeal/Oropharyngeal/Mid-turbinate swab. D. Storage and Stability Storage in the original packaging at room temperature (18-25 ℃) and has a shelf-life of 18 months.