Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008311438

FEI Number

3008311438

Entity Name

B&E BIO-TECHNOLOGY CO., LTD.

City/State/Country

Yantai Shandong, CN

Establishment Address

No.11 Jieaisi Road,Laishan District, Yantai Shandong 264003, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B&E BIO-TECHNOLOGY CO., LTD. (Owner Number: 10031852)

Owner / Operator Contact Address

No.11 Jieaisi Road,Laishan District, No.10 Baoyuan Road,Laishan District, Yantai, CN-SD 264003, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B&E 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2010-03-31
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2010-03-31
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2016-01-12
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2010-03-24
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2010-03-24
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2010-03-24
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2024-12-05

Official Correspondent

LIU XINLEI

US Agent Details

Cathy zhu Business: B & E Biomedical Inc Email: xinlei.liu@besic.cn Phone: (630) 9745159

Related Public Records

Same Entity

B&E BIO-TECHNOLOGY CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

Similar Registrations

Registration Number	Establishment Name	Location
3011661720	TRUCKEE APPLIED GENOMICS INC	Reno, NV, US
3005504113	KEMENTEC SOLUTIONS AS	Taastrup Hovedstaden, DK
3005181013	TAKARA BIOTECHNOLOGY (DALIAN) CO., LTD.	Dalian Liaoning, CN
3006537286	AUTOBIO DIAGNOSTICS CO., LTD.	Zhengzhou Henan, CN
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008311438. Last updated year: 2026. Please use registration number 3008311438 when referencing this establishment in official correspondence.