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KogeneBiotech Co., Ltd.

South Korea·KR-MF-000045858

Last updated September 18, 2026

About

KOGEN Biotech is a leading solution provider of molecular diagnostics for human and animal infections and food and environment

Translated from the manufacturer's own website. Source

What KogeneBiotech Co., Ltd. makes

KogeneBiotech Co., Ltd. manufactures real-time PCR diagnostic kits for detecting specific viral and bacterial pathogens, including adenovirus, astrovirus, rotavirus, coronaviruses (including SARS-CoV-2), influenza A&B, respiratory syncytial virus (RSV), parainfluenza viruses, mumps, Zika virus, dengue virus, and chikungunya virus. The company also produces multiplex PCR kits that enable simultaneous identification of multiple pathogens, as well as a viral DNA/RNA extraction kit for sample preparation.

These diagnostic products fall under Class A and In Vitro Diagnostic (IVD) General device classifications, with some listed in the EU’s eudamed registry. The company is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
South Korea
Address
13F, 146, Gasan digital 1-ro, Geumcheon-gu, Seoul , South Korea
LinkedIn
—
Facebook
—
Phone
+82 2 2026 2150, +82 2 2059 1160
PRRC Contact
Jin Hyuck Kim
EUDAMED SRN
KR-MF-000045858
FDA FEI Number
—
DUNS Number
—

Catalogue (29)

DeviceModel / ReferenceRegistriesClassStatus
PowerChek™ Adeno / Astro / Rota Real-time PCR Kit R0211E
EUDAMED
IVD GeneralActive
PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0 R6410TA
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2 Real-time PCR Kit IR6902
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit IR6903N
EUDAMED
IVD GeneralActive
PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit R5504
EUDAMED
IVD GeneralActive
PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1 R3013TA
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit IR6903Q
EUDAMED
IVD GeneralActive
PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit R6200T
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II R6905Q
EUDAMED
IVD GeneralActive
PowerChek™ 20 Bacterial Panel Kit R1501
EUDAMED
IVD GeneralActive
PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 E0016
EUDAMED
Class AActive
PowerChek™ Mumps Real-time PCR Kit Ver.1.1 R3110TA
EUDAMED
IVD GeneralActive
PowerChek™ MTB/NTM Real-time PCR Kit IR0120
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit IR6906
EUDAMED
IVD GeneralActive
PowerChek™ 18 RV Panel Kit CQ13TTO6002Z
EUDAMED
IVD GeneralActive
PowerChek™ Salmonella Triplex Real-time PCR Kit R0152E
EUDAMED
IVD GeneralActive
PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ CQ19TTO0003Z
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II R6905N
EUDAMED
IVD GeneralActive
PowerChek™ MeV / MeVA Multiplex Real-time PCR Kit R3136TA
EUDAMED
IVD GeneralActive
PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit R0210E
EUDAMED
IVD GeneralActive
PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit IR3600
EUDAMED
IVD GeneralActive
PowerChek™ Measles virus Real-time PCR Kit Ver.1.0 R3130TA
EUDAMED
IVD GeneralActive
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit IR6904
EUDAMED
IVD GeneralActive
PowerPrep™ Viral NA Extraction Kit EXP E0017S
EUDAMED
Class AActive
PowerPrep™ Viral NA Extraction Kit EXP E0017
EUDAMED
Class AActive
PowerPrep™ Pathogen NA Extraction Kit EXP E0019
EUDAMED
Class AActive
PowerEXP™ 48LH KE4800
EUDAMED
Class AActive
PowerPrep™ Pathogen NA Extraction Kit EXP E0019S
EUDAMED
Class AActive
PowerPrep™ Whole blood NA Extraction Kit EXP E0018
EUDAMED
Class AActive

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