Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017485950

FEI Number

3017485950

Entity Name

SML GENETREE CO. LTD.

City/State/Country

Seoul, KR

Establishment Address

1307-1309, 167 Songpa-daero, Songpa-gu, Seoul 05855, KR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SML Genetree Co. Ltd. (Owner Number: 10076632)

Owner / Operator Contact Address

1307-1309, 167, Songpa-daero, Songpa-gu, Seoul, KR-11 05855, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ezplex SARS-CoV-2 G Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

Sujung Park Email: spark@fidealaw.com Phone: (408) 2367345

Related Public Records

Same Entity

SML Genetree 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-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Similar Registrations

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3014553740	STAT-Dx Life, S.L.	Barcelona, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017485950. Last updated year: 2026. Please use registration number 3017485950 when referencing this establishment in official correspondence.