Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026312356

FEI Number

3026312356

Entity Name

SUZHOU TIANLONG BIOTECHNOLOGY CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building NE-33, Nanopolis, No.99 Jinjihu Avenue, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone, Suzhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou TianLong Biotechnology Co., Ltd. (Owner Number: 10086573)

Owner / Operator Contact Address

Building NE-33, Nanopolis, No.99 Jinjihu Avenue, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone, Suzhou, CN-JS 215123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method) Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method) CT/NG/UU/UP Nucleic Acid Multiplex Detection Kit Legionella Pneumophila Nucleic Acid Detection Kit (Fluorescence PCR Method) Salmonella Enterica/Shigella Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2022-12-29
JSX	Kit, Identification, Neisseria Gonorrhoeae	Microbiology	Class 1	866.2660	2022-12-29
LQH	Dna-Reagents, Legionella	Microbiology	Class 2	866.3300	2022-12-29
GNB	Antisera, All Types, Shigella Spp.	Microbiology	Class 2	866.3660	2022-12-29

Official Correspondent

Yangyang Wu

US Agent Details

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

Related Public Records

Same Entity

Suzhou TianLong Biotechnology 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 3026312356. Last updated year: 2026. Please use registration number 3026312356 when referencing this establishment in official correspondence.