FDA Registration
Active
🇰🇷 South Korea
Nextractor NX-Jr
Reg #: 3013096769
·
FEI: 3013096769
·
Expires 2025
Products
1
Proprietary Names
105
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Genolution Inc
- Registration Number
- 3013096769
- FEI Number
- 3013096769
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm 101-104, 301-305 , 120, Gaetbeol-ro, Yeonsu-gu
- City
- Inchecon Incheon
- Country
- KR
Owner / Operator
- Firm Name
- Genolution Inc.
- Operator Number
- 10052785
- Address
- Genolution Bldg. 63 Magok Jungang 8-ro 3-gil,, Gangseo-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 07793
- Country
- KR
- Correspondent
- Junho Hwang
US Agent
- Business Name
- EK Health Services, Inc.
- Contact Name
- Sang Hoon Kim
- Address
- 992 S. De Anza Blvd. Suite 101
- City
- San Jose
- State
- CA
- ZIP
- 95129
- Country
- US
- [email protected]
- Phone
- 408 9730888 ext. 138
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2016-10-05 |
Proprietary Names
Nextractor NX-Jr
NX Bacterial DNA Kit CBD293
NX Stool RNA Kit CSR231
NX Viral RNA kit CVR231
Nextractor NX-Duo
NX Bacterial DNA Kit CBD233
NX Viral NA Kit CVN291
NX Universal NA Kit A NUE961
NX Genomic DNA Kit B NGD042
NX-Duo Bacterial DNA Kit B DBD482
NX-Duo Universal DNA Kit C DUE963
NX Viral NA Kit CVN292
NX Universal DNA Kit B NUE962
NX-Jr Bacterial DNA Kit BD136
NX-Duo Stool NA Kit A DSN481
NX-Duo Bacterial DNA Kit A DBD241
NX-Duo Universal DNA Kit B DUE482
NX-Jr Viral DNA Kit VD131
NX-Duo Bacterial DNA Kit C DBD483
NX Genomic DNA Kit B NGD322
NX-Jr Universal DNA Kit C JUE063
NX FFPE DNA Kit CFF231
NX Universal DNA Kit C NUE323
NX-Duo Bacterial DNA Kit A DBD961
NX Viral NA Kit CVN293
NX-Jr Stool RNA Kit SR131
NX-Duo Bacterial DNA Kit C DBD963
NX Genomic DNA Kit B NGD962
NX-Jr Universal DNA Kit B JUE062
Nextractor NX-48
NX Bacterial DNA Kit CBD291
NX Viral DNA kit CVD231
NX Stool DNA Kit CSD231
NX Genomic DNA Kit A NGD231
NX-Jr Viral RNA Kit VR132
Nextractor NX-48S
NX Bacterial DNA Kit CBD231
NX Viral RNA kit CVR291
NX Stool NA Kit A CSN231
Nextractor NX-32N
NX Bacterial DNA Kit CBD243
NX Viral NA Kit CVN231
NX Universal NA Kit A NUE321
NX-Jr Bacterial DNA Kit BD131
NX Stool NA Kit A CSN241
NX-Duo Viral NA Kit A DVN961
NX-Jr Genomic DNA Kit B JGD062
NX Viral NA Kit CVN232
NX-Jr FFPE DNA Kit FF131
NX Viral NA Kit CVN242
NX-Jr Stool DNA Kit SD131
NX-Duo Universal NA Kit A DUE961
NX-Duo Genomic DNA Kit B DGD242
NX-Duo Bacterial DNA Kit A DBD481
NX-Duo Universal DNA Kit B DUE962
NX Viral NA Kit CVN233
NX-Jr Viral NA Kit VN131
NX-Duo Bacterial DNA Kit B DBD962
NX-Duo Universal DNA Kit B DUE242
NX-Jr Viral RNA Kit VR131
NX-Duo Stool NA Kit A DSN961
NX-Duo Universal DNA Kit C DUE243
NX Stool DNA Kit CSD241
NX Genomic DNA Kit A NGD961
NX-Duo Bacterial DNA Kit C DBD243
NX-Jr Genomic DNA Kit A JGD061
NX Viral NA Kit CVN241
NX Universal NA Kit A NUE041
NX-Jr Bacterial DNA Kit BD133
NX-Duo Genomic DNA Kit B DGD962
NX FFPE DNA Kit CFF291
NX Universal DNA Kit B NUE042
NX-Duo Genomic DNA Kit A DGD961
NX Bacterial DNA Kit CBD296
NX FFPE DNA Kit CFF241
NX Universal DNA Kit C NUE963
NX-Duo Universal DNA Kit C DUE483
NX-Duo Stool NA Kit A DSN241
NX-Duo Genomic DNA Kit A DGD481
NX Bacterial DNA Kit CBD236
NX-Duo Viral NA Kit A DVN481
NX-jr Microorganism DNA Kit MD131
NX-Duo Universal NA Kit A DUE241
NX-Duo cfDNA Kit A DCF244
NX Viral DNA kit CVD291
NX-Duo Bacterial DNA Kit B DBD242
NX Stool RNA Kit CSR291
NX Genomic DNA Kit A NGD041
NX-Jr Universal NA Kit A JUE061
NX-Duo Genomic DNA Kit A DGD241
NX Bacterial DNA Kit CBD246
NX Universal DNA Kit B NUE322
Nextractor NX-48N
NX Bacterial DNA Kit CBD241
NX Stool RNA Kit CSR241
NX Viral RNA kit CVR241
NX Stool DNA Kit CSD291
NX Universal DNA Kit C NUE043
NX Stool NA Kit A CSN291
Viral NA Kit VN001
NX-Duo Viral NA Kit A DVN241
NX-Duo Genomic DNA Kit B DGD482
NX-Duo Universal NA Kit A DUE481
NX-Duo cfDNA Kit A DCF242
NX Viral NA Kit CVN243
Establishment Types
Manufacture Medical Device