K-number	K250205
Device name	Babio® Virus Transport Kit (Non-inactivating)
Applicant	Jinan Babio Biotechnology Co., Ltd.
Product code	JSM
Device class	Class I
Decision date	Sep 22, 2025
Decision	Substantially Equivalent
Regulation	866.2390

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Babio Virus Transport Kit (Non-inactivating) is a culture-based medium designed for collecting and transporting clinical specimens containing viral agents—specifically Influenza A, Herpes Simplex Virus-1, and Adenovirus—from collection sites to testing laboratories. The medium preserves viable, infectious viral particles for standard virus culture and diagnostic assays.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Babio® Virus Transport Kit (Non-inactivating)

Everything you need for a 510(k) submission. Nothing you don't.