Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014100717

FEI Number

3014100717

Entity Name

GENRUI BIOTECH INC

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

4-10F, Building 3, Geya Technology Park, Guangming District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Genrui Biotech Inc (Owner Number: 10056079)

Owner / Operator Contact Address

4-10 Floors, Building 3, Geya Technology Park, Guangming District, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Handheld Dry Fluorescence Immunoassay Analyzer FA20;Quantitative Immunoassay Analyzer FA30, FA31 Fully-auto Specific Protein Analyzer PA480S, PA480,PA240S, PA240 Genrui Specific Protein Analyzer PA50/54 Genrui Specific Protein Analyzer PA120 Genrui Specific Protein Analyzer PA200 Quantitative Immunoassay Analyzer FA50, FA51, FA52, FA53, FA54 Fully-Auto Nucleic Acid Extraction Instrumen Nucleic Acid Extraction Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JZT	Fluorometer	Immunology	Class 1	866.4520	2025-05-30
JZW	Nephelometer	Immunology	Class 1	866.4540	2017-11-03
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2018-05-10
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2020-08-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Genrui Biotech Inc

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
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014100717. Last updated year: 2026. Please use registration number 3014100717 when referencing this establishment in official correspondence.