Jinan Babio Biotechnology Co., Ltd.
Manufacturer and brand owner in Jinan, Shandong, China. 25 device types, 3 products catalogued, 1 clearance.
Jinan Babio Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Eosin Y, Hematoxylin and 23 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
25device types registered with the FDA
3products catalogued under its own name
1510(k) clearance
Registration
| Registered name | JINAN BABIO BIOTECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016741564 |
| FEI number | 3016741564 |
| DUNS | 527015617 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 济南百博生物技术股份有限公司 |
|---|---|
| Unified social credit code | 913701007563575874 |
| Source | NMPA UDI database |
Location
| City | Jinan |
|---|---|
| Province | Shandong |
| Address | 303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone |
| Postal code | 250101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Disposable Sampling Swab (Non-Sterile), Swab, Vaginal microbiome detection kit (dry chemical method) | 2021 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Disposable Sampling Swab (Sterile), Disposable Sampling Swab | 2020 | 100 |
| Block, Heating | Class 1 | Sample treatment and Incubation System (T-80), Microbial sample pretreatment system (ET-800+) | 2024 | 6 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Cary-Blair Transport Media, Modified Cary-Blair Transport Media | 2021 | 51 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Liquid Amies Media, Virus Transport Kit (Non-Inactivated) | 2023 | 33 |
| Container, Specimen, Non-Sterile | Class 1 | Viral Transport Tube, Liquid Amies Media, Virus Transport Kit (Non-Inactivated) | 2020 | 115 |
| Culture Media, Enriched | Class 1 | Columbia Blood Agar Medium | 2025 | 1 |
| Culture Media, Non-Propagating Transport | Class 1 | Babio® Virus Transport Kit (Non-inactivating) | 2025 | 11 |
| Culture Media, Non-Selective And Differential | Class 1 | Intestinal bacteria agar medium, Salmonella Shigella Agar, XLD Agar Medium, Thiosulfate Citrate Bile Salts Sucrose Agar Medium | 2025 | 2 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Lecithin Tween Tryptone Soy Agar Medium, Dehydrated Culture Media, Transport medium, Disposable Sampling Swab Regular Swab with Amies Agar Gel Medium, Mueller-Hinton Agar | 2020 | 18 |
| Culture Media, Selective And Non-Differential | Class 1 | Sabouraud Agar Medium, MacConkey Agar, Sabouraud Dextrose Agar Medium(SDA) | 2025 | 1 |
| Discs, Strips And Reagents, Microorganism Differentiation | Class 1 | Vaginal microbiome detection kit (dry chemical method) | 2025 | 4 |
| Eosin Y | Class 1 | Hematoxylin eosin staining solution kit | 2024 | 4 |
| Fluid, Bouin’S | Class 1 | Tissue fixative | 2024 | 2 |
| General Purpose Reagent | Class 1 | Potato Dextrose AGAR Medium (PDA), Mold Detection Plate | 2020 | 30 |
| Giemsa Stain | Class 1 | Liu’s Dye Solution Kit, Reichs-Giemsa Dye Solution, Jimsa Dye Solution Kit | 2024 | 1 |
| Hematoxylin | Class 1 | Hematoxylin eosin staining solution kit | 2024 | 3 |
| Iodine, Grams | Class 1 | Acid fast staining solution (fluorescence method) kit, Rapid Gram dye solution kit, Acid fast staining solution kit | 2024 | 1 |
| Kit, Mycoplasma Detection | Class 1 | Mycoplasma Pneumoniae lgM Test Kit (Colloidal Gold) | 2022 | 1 |
| Microbial Nucleic Acid Storage And Stabilization Device | Class 2 | Virus Transport Kit (Inactivated) | 2021 | 3 |
| Oil, Clearing | Class 1 | Premium oil mirror oil | 2024 | 3 |
| Saline, Vascular Access Flush | Class 2 | Normal Saline | 2021 | 10 |
| Stain, Papanicolau | Class 1 | Liu’s Dye Solution Kit, Pap staining solution kit | 2024 | 4 |
| Stain, Reticulocyte | Class 1 | Reticulocyte staining solution kit, Liu’s Dye Solution Kit | 2024 | 1 |
| Transport Medium, Notified Per The Vtm Guidance | Class 1 | Babio® Virus Transport Kit (Non-Inactivated) | 2021 | 5 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250205 | 2025-09-22 | JSM | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Rapid detection kits, Culture media, Clinical reagents, Diagnostic equipment, Antigen rapid test kits |
| Certifications | ISO9001:2008, ISO13485:2003 |
| Export markets | Global (30+ language support) |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | 70 |
| Labpeak Co., Ltd. | 43 |
| Scitek Global Co., Ltd. | 43 |
| Shandong Lianfa Medical Plastic Products Co., Ltd. | 3 |
| Shandong Corecare Technology Limited | 2 |
| Dragon Crown Medical Co., Ltd. | 2 |
| Shandong Lening Medical Technology Co., Ltd. | 1 |
| Onehalf Design Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.