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Data / Medical devices / China / Jinan Babio Biotechnology Co.,ltd.

Jinan Babio Biotechnology Co.,ltd.: FDA-registered device maker in Jinan City Shandong, China, 1 510(k) clearance

Jinan Babio Biotechnology Co.,ltd. is registered with the FDA (registration 3016741564) in Jinan City Shandong, China. It lists 25 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Jinan Babio Biotechnology Co.,ltd.
FDA registration number
3016741564
Address
303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone, Jinan City Shandong, China, 250101
Owner or operator
JINAN BABIO BIOTECHNOLOGY CO.,LTD. (10066753)
Roles
Exporter to the US, Manufacturer
First device listed
April 2, 2020
Registered through
2026
Brand names listed
Acid fast staining solution (fluorescence method) kit, Acid fast staining solution kit, Babio® Virus Transport Kit (Non-Inactivated), Babio® Virus Transport Kit (Non-inactivating), Cary-Blair Transport Media, Columbia Blood Agar Medium, Dehydrated Culture Media, Disposable Sampling Swab and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Exporter to the US, Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Exporter to the US, Manufactureraccessdata.fda.gov
Block, HeatingJRG1Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Exporter to the US, Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the US, Manufactureraccessdata.fda.gov
Culture Media, EnrichedKZI1Exporter to the US, Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Exporter to the US, Manufactureraccessdata.fda.gov
Culture Media, Non-Selective And DifferentialJSH1Exporter to the US, Manufactureraccessdata.fda.gov
Culture Media, Non-Selective And Non-DifferentialJSG1Exporter to the US, Manufactureraccessdata.fda.gov
Culture Media, Selective And Non-DifferentialJSJ1Exporter to the US, Manufactureraccessdata.fda.gov
Discs, Strips And Reagents, Microorganism DifferentiationJTO1Exporter to the US, Manufactureraccessdata.fda.gov
Eosin YHYB1Exporter to the US, Manufactureraccessdata.fda.gov
Fluid, Bouin'SIGN1Exporter to the US, Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Exporter to the US, Manufactureraccessdata.fda.gov
Giemsa StainHYF1Exporter to the US, Manufactureraccessdata.fda.gov
HematoxylinHYJ1Exporter to the US, Manufactureraccessdata.fda.gov
Iodine, GramsHYI1Exporter to the US, Manufactureraccessdata.fda.gov
Kit, Mycoplasma DetectionKIW1Exporter to the US, Manufactureraccessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization DeviceQBD2Exporter to the US, Manufactureraccessdata.fda.gov
Oil, ClearingIJZ1Exporter to the US, Manufactureraccessdata.fda.gov
Saline, Vascular Access FlushNGT2Exporter to the US, Manufactureraccessdata.fda.gov
Stain, PapanicolauHZJ1Exporter to the US, Manufactureraccessdata.fda.gov
Stain, ReticulocyteGJH1Exporter to the US, Manufactureraccessdata.fda.gov
Transport Medium, Notified Per The Vtm GuidanceQMC1Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 22, 2025K250205Babio® Virus Transport Kit (Non-inactivating)JSMSubstantially EquivalentJinan Babio Biotechnology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.