Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012452932

FEI Number

3012452932

Entity Name

DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

No. 2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA, Tianjin300467, Tianjin 300467, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dynamiker Biotechnology (Tianjin) Co., Ltd. (Owner Number: 10060616)

Owner / Operator Contact Address

No. 2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA, Tianjin300467, Tianjin, CN-TJ 300467, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA) QuicIgG^TM Aspergillus IgG Ab Lateral Flow Assay Dynamiker Aspergillus fumigatus IgG Assay Dynamiker Candida IgG Lateral Flow Assay(LFA) Dynamiker Candida Mannan Assay Dynamiker Candida albicans IgG Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDU	Antigen, Elisa, Cryptococcus	Microbiology	Class 2	866.3165	2019-06-02
JWT	Antigen, Cf, Aspergillus Spp.	Microbiology	Class 1	866.3040	2019-06-02
LSG	Candida Species, Antibody Detection	Microbiology	Class 2	866.3165	2019-06-02

Official Correspondent

Di Li

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Dynamiker Biotechnology (Tianjin) 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 3012452932. Last updated year: 2026. Please use registration number 3012452932 when referencing this establishment in official correspondence.