BABIO’s Virus Transport Kit Earns FDA 510(k) Clearance

2025-10-30

BABIO’s Virus Transport Kit Earns FDA 510(k) Clearance

Jinan, China – October 2025 — BABIO Biotechnology, a renowned Chinese manufacturer of medical diagnostic reagents, proudly announces that its Virus Transport Kit (Non-inactivating) has received FDA 510(k) clearance (K250205), officially validating its compliance with U.S. regulatory standards.

This milestone reinforces BABIO’s global leadership in clinical specimen transport solutions. The kit is engineered for safe and stable collection of viral samples, supporting downstream applications such as RT-PCR, viral culture, and molecular diagnostics. It features:

  • Room temperature stability

  • Improved Hank’s solution with antibiotics

  • DNase/RNase-free conical tubes

  • Safe flocking swabs with breakpoint design

Available in multiple fill volumes (1ml–6ml) and package sizes (20–500 tubes), the kit is ideal for hospitals, laboratories, and public health institutions worldwide.

With a daily production capacity of 100,000 units, BABIO ensures consistent supply and competitive pricing. Trusted in the United States, Germany, and beyond, BABIO continues to deliver innovation and reliability in virus transport systems.Learn more at https://www.babiocorp.com.

#VirusTransportKit #FDA510k #BABIO #ClinicalDiagnostics #VTM #RT-PCR #GlobalHealthcare #MedicalDevices #SpecimenCollection

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