FDA Registration
Active
🇨🇳 China
B&E BIO-TECHNOLOGY CO., LTD.
Reg #: 3008311438
·
FEI: 3008311438
·
Expires 2026
Products
9
Proprietary Names
15
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- B&E BIO-TECHNOLOGY CO., LTD.
- Registration Number
- 3008311438
- FEI Number
- 3008311438
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.11 Jieaisi Road,Laishan District
- City
- Yantai Shandong
- Country
- CN
Owner / Operator
- Firm Name
- B&E BIO-TECHNOLOGY CO., LTD.
- Operator Number
- 10031852
- Address
- No.11 Jieaisi Road,Laishan District, No.10 Baoyuan Road,Laishan District
- City
- Yantai
- State
- Shandong
- Postal Code
- 264003
- Country
- CN
- Correspondent
- LIU XINLEI
US Agent
- Business Name
- B & E Biomedical Inc
- Contact Name
- Cathy zhu
- Address
- 3830 Montone Ave
- City
- Las Vegas
- State
- NV
- ZIP
- 89141
- Country
- US
- [email protected]
- Phone
- 630 9745159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2010-03-31 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2010-03-31 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2016-01-12 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2010-03-24 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2010-03-24 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2010-03-24 |
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2024-12-05 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2023-05-10 |
| Detergent | JCB | Class 1 | Pathology | No | 2010-03-25 |
Proprietary Names
B&E
Diluit-3 Diff;Diluit-BC;Diluit-BC-5Diff;Diluit-5Diff
Diluit-Sys-DCCL;Diluit-Sys-DCFL;Diluit-Sys-DCST;Diluit-Sys;Diluit-Sys-Retic;Sheath-Sys
Diluit-ABX-5Diff;Diluit-OT
Sheath-Ruby;Diluit/sheath-Mythic
Lyse-ABX-HGB;Lyse-ABX-EO;Lyse-ABX-BA;Lyse-ABX3
Lyse-sys-BA;Lyse-sys-4DL;Lyse-sys-NR ;Lyse-sys-IM ;Lyse-KX;Lyse-K-WBC
Lyse-sys-SLLS; Lys-sys-WCDF; Lyse-sys-WCNR; Lyse-sys-WCPC
Lyse-Diff I-DxH;Lyse-Diff II-DxH;Lyse-Retic B-DxH;Lyse-3 Diff
Lyse-DynWBC;Lyse-Dyn32HGB;Lyse-Mythic5
Lyse-BC;Lyse-BC-58 EOII;Lyse-BC-58 EOI;Lyse-BC-53H;Lyse-BC-53EOI; Lyse-BC-53EOII
Dye-Dyn37-Retic;Dye-Retic A-DxH
Dye-XN-PLT;Dye-XN-RET;Dye-XN-WCDF;Dye-XN-WCNR;Dye-XN-WCPC;Dye-sys-4DS;Dye-sys-Retic;Dye-sys-NR
Sys-cal
Probe-Cleaner;EZ-Cleaner Concentrate;EZ-Cleaner;EZ-HiCleaner;Rinse
Establishment Types
Manufacture Medical Device