Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006537286

FEI Number

3006537286

Entity Name

AUTOBIO DIAGNOSTICS CO., LTD.

City/State/Country

Zhengzhou Henan, CN

Establishment Address

Offical adress: No.87 Jingbei Yi Road, National Eco &Tech Development Area, Facility adress: No.199, 15th Ave, National Eco &Tech Zone, Zhengzhou Henan 450016, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Autobio Diagnostics Co., Ltd. (Owner Number: 10066108)

Owner / Operator Contact Address

Offical adress: No.87 Jingbei Yi Road, National Eco &Tech Development Area, Facility adress: No.199, 15th Ave, National Eco &Tech Zone, Zhengzhou, CN-HA 450016, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wash Buffer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-05-15

Official Correspondent

Hezi Zhang

US Agent Details

Iris Xi Business: AdvanBio Inc Email: jimmy.Ji@Advan-Bio.Com Phone: (949) 2692396

Related Public Records

Same Entity

Autobio Diagnostics Co., Ltd.

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

View Entity Profile →

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
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB
3013452222	PREOMICS GMBH	Planegg/Martinsried Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006537286. Last updated year: 2026. Please use registration number 3006537286 when referencing this establishment in official correspondence.