Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025430789

FEI Number

3025430789

Entity Name

AUTOBIO LABTEC INSTRUMENTS CO., LTD.

City/State/Country

Zhengzhou Henan, CN

Establishment Address

No. 199, 15th Ave, National Eco & Tech Zone, Zhengzhou Henan 450016, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Autobio Labtec Instruments Co., Ltd. (Owner Number: 10086518)

Owner / Operator Contact Address

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

Automated Nucleic Acid Purification and Real Time PCR System Chemiluminescence Immunoassay Analyzer: AutoLumo A2000 Plus,AutoLumo A1000,AutoLumo A1820&A1860, AutoLumo A6200&A6600

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-11-15
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2022-11-15

Official Correspondent

Fangfang Bai

US Agent Details

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

Related Public Records

Same Entity

Autobio Labtec Instruments Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Similar Registrations

Registration Number	Establishment Name	Location
3026886124	ROCGENE(XUZHOU) TECHNOLOGY LIMITED	Xuzhou Jiangsu, CN
1524213	MERIDIAN BIOSCIENCE, INC.	Cincinnati, OH, US
3004530258	CEPHEID	Sunnyvale, CA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025430789. Last updated year: 2026. Please use registration number 3025430789 when referencing this establishment in official correspondence.