Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013096769

FEI Number

3013096769

Entity Name

Genolution Inc

City/State/Country

Inchecon Incheon, KR

Establishment Address

Rm 101-104, 301-305 , 120, Gaetbeol-ro, Yeonsu-gu, Inchecon Incheon 21999, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genolution Inc. (Owner Number: 10052785)

Owner / Operator Contact Address

Genolution Bldg. 63 Magok Jungang 8-ro 3-gil,, Gangseo-gu, Seoul, KR-11 07793, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NX Viral NA Kit CVN291 NX Universal NA Kit A NUE961 NX-Jr Genomic DNA Kit A JGD061 NX-Duo Stool NA Kit A DSN961 NX Bacterial DNA Kit CBD296 NX FFPE DNA Kit CFF291 NX Viral NA Kit CVN242 NX-Duo Bacterial DNA Kit B DBD242 NX Viral RNA kit CVR291 NX Genomic DNA Kit A NGD041 NX-Duo Viral NA Kit A DVN961 NX-Duo Genomic DNA Kit A DGD241 NX-Jr Bacterial DNA Kit BD131 Nextractor NX-48 NX-Duo Bacterial DNA Kit A DBD241 NX Viral NA Kit CVN243 NX-Duo Universal NA Kit A DUE961 NX Universal DNA Kit B NUE322 NX-jr Microorganism DNA Kit MD131 NX-Duo Bacterial DNA Kit A DBD481 NX FFPE DNA Kit CFF231 NX Viral NA Kit CVN233 NX-Duo Bacterial DNA Kit A DBD961 NX-Duo Universal NA Kit A DUE241 NX Universal DNA Kit C NUE963 NX-Duo cfDNA Kit A DCF242 NX Stool DNA Kit CSD291 NX-Jr Stool DNA Kit SD131 NX-Jr Viral DNA Kit VD131 NX-Duo Bacterial DNA Kit C DBD243 NX-Duo Genomic DNA Kit A DGD481 NX Genomic DNA Kit B NGD042 Viral NA Kit VN001 NX-Duo Genomic DNA Kit B DGD482 NX-Jr Bacterial DNA Kit BD136 NX-Jr Stool RNA Kit SR131 Nextractor NX-48N NX-Duo Bacterial DNA Kit B DBD482 NX Viral DNA kit CVD231 NX Genomic DNA Kit A NGD231 NX Bacterial DNA Kit CBD246 NX Viral NA Kit CVN232 NX Bacterial DNA Kit CBD291 NX Stool DNA Kit CSD231 NX-Jr Viral RNA Kit VR132 NX Viral NA Kit CVN231 NX Universal NA Kit A NUE321 NX-Jr Genomic DNA Kit B JGD062 NX-Duo cfDNA Kit A DCF244 NX Stool DNA Kit CSD241 NX-Jr Viral RNA Kit VR131 NX-Duo Stool NA Kit A DSN481 NX Viral NA Kit CVN241 NX Universal NA Kit A NUE041 NX-Duo Stool NA Kit A DSN241 NX-Duo Viral NA Kit A DVN241 NX Viral NA Kit CVN292 NX Universal DNA Kit B NUE962 Nextractor NX-Jr NX Bacterial DNA Kit CBD231 NX Stool RNA Kit CSR291 NX-Jr Universal NA Kit A JUE061 NX Stool NA Kit A CSN291 Nextractor NX-48S NX-Duo Bacterial DNA Kit B DBD962 NX Viral DNA kit CVD291 NX FFPE DNA Kit CFF241 NX Viral NA Kit CVN293 NX-Duo Universal DNA Kit B DUE962 NX Universal DNA Kit C NUE323 NX Bacterial DNA Kit CBD236 Nextractor NX-Duo NX Stool RNA Kit CSR241 NX-Jr Universal DNA Kit B JUE062 NX Stool NA Kit A CSN231 Nextractor NX-32N NX Stool RNA Kit CSR231 NX-Jr Universal DNA Kit C JUE063 NX-32N FFPE RNA Kit A CFR361 NX Stool NA Kit A CSN241 NX-32N FFPE DNA Kit A CFF361 NX-Duo Genomic DNA Kit B DGD242 NX-Jr FFPE DNA Kit FF131 NX-Jr Viral NA Kit VN131 NX-32N FFPE DNA Kit A CFF391 NX-Duo Universal DNA Kit C DUE243 NX Bacterial DNA Kit CBD243 NX-Duo Universal DNA Kit C DUE963 NX Bacterial DNA Kit CBD293 NX-Duo Viral NA Kit A DVN481 NX-Duo Genomic DNA Kit B DGD962 NX-Jr Bacterial DNA Kit BD133 NX-Duo Universal DNA Kit B DUE482 NX Universal DNA Kit C NUE043 NX-Duo Universal DNA Kit B DUE242 NX Bacterial DNA Kit CBD241 NX Genomic DNA Kit A NGD961 NX-Duo FFPE RNA Kit A DFR481 NX-32N FFPE RNA Kit A CFR391 NX-Duo Bacterial DNA Kit C DBD483 NX-Duo Genomic DNA Kit A DGD961 NX Viral RNA kit CVR231 NX Genomic DNA Kit B NGD322 NX-Duo Universal NA Kit A DUE481 NX Universal DNA Kit B NUE042 NX Viral NA Kit VN153 NX-Duo Universal DNA Kit C DUE483 NX Bacterial DNA Kit CBD233 NX-Duo Bacterial DNA Kit C DBD963 NX Viral RNA kit CVR241 NX Genomic DNA Kit B NGD962 NX-Jr FFPE RNA Kit A FR131 NX-Duo FFPE RNA Kit A DFR961 NX Viral NA Kit VN163 NX-Duo FFPE RNA Kit A DFR241 NX Viral NA Kit VN143

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2016-10-05

Official Correspondent

Kyu-jin Hong

US Agent Details

Sang Hoon Kim Business: EK Health Services, Inc. Email: shk6854@yahoo.co.kr Phone: (408) 9730888

Related Public Records

Same Entity

Genolution Inc.

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 3013096769. Last updated year: 2026. Please use registration number 3013096769 when referencing this establishment in official correspondence.