Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031606509

FEI Number

3031606509

Entity Name

DIAGLOGIC BIOLABS (XIAMEN) CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

21-3F Shanbianhong East Road, Haicang District, Xiamen Fujian 361028, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diaglogic Biolabs (Xiamen) Co., Ltd. (Owner Number: 10090958)

Owner / Operator Contact Address

21-3F Shanbianhong East Road, Haicang District, Xiamen, CN-FJ 361028, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diaglogic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2024-06-14

Official Correspondent

Xiaoqun Jiang

US Agent Details

Peter Mousseau Business: Rainbow Scientific, Inc. Email: PMousseau@rainbowscientific.com Phone: (860) 2988382

Related Public Records

Same Entity

Diaglogic Biolabs (Xiamen) Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031606509. Last updated year: 2026. Please use registration number 3031606509 when referencing this establishment in official correspondence.