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Biosci Inactivated Transport Medium, Biosci ITM

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220059

by Shenzhen Dakewe Bio-Engineering Co., Ltd.

Identifiers

510(k) Number
K220059 FDA 510(k)
FDA Product Code
QBD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.2950 FDA 510(k)
Regulation Number
866.2950 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Biosci Inactivated Transport Medium (ITM) is a microbial nucleic acid storage and stabilization device designed for preserving inactivated microbial specimens. It maintains sample integrity for downstream molecular testing, ensuring reliable detection of nucleic acids while preventing degradation during transport and storage.

This medium is supplied as a sterile, single-use solution intended for microbiology applications. It complies with FDA 510(k) and IVDR regulations, with a classification as a Class II device under the FDA’s microbial nucleic acid storage and stabilization category. The product is packaged for laboratory use and must be stored according to manufacturer instructions to preserve sterility and efficacy.

Frequently asked questions

What is the primary purpose of the Biosci™ Inactivated Transport Medium (ITM) in a laboratory setting?

The Biosci™ ITM is designed specifically to preserve and stabilize inactivated microbial specimens, ensuring their integrity for downstream molecular testing. It prevents nucleic acid degradation during transport and storage, which is critical for reliable detection in microbiology applications.

Is the Biosci™ ITM intended for reuse or is it meant to be used only once?

The Biosci™ ITM is supplied as a single-use solution, meaning each package is intended for one-time use only. This design helps maintain sterility and prevent cross-contamination in microbiology workflows.

How should the Biosci™ ITM be stored to ensure it remains effective and sterile?

The product must be stored according to the manufacturer’s instructions to preserve sterility and efficacy. While the exact storage conditions (e.g., temperature, humidity) aren’t detailed here, typical microbial transport media require refrigeration or room-temperature storage away from direct light, as outlined in the accompanying documentation.

What regulatory pathways has the Biosci™ ITM followed, and what does that mean for its use?

The Biosci™ ITM has undergone FDA 510(k) clearance and complies with IVDR (In Vitro Diagnostic Regulation) standards, classifying it as a Class II device under the FDA’s microbial nucleic acid storage and stabilization category. This means it meets stringent safety and performance requirements for laboratory use in microbiology, ensuring reliability for nucleic acid testing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Dakewe Bio-Engineering Co., Ltd.

Sources (2)

  • FDA 510(k) K220059 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026