Manufacturer

Kogene

South KoreaLegal entities : KogeneBiotech Co., Ltd.

First countries of placing on the market declared in EUDAMED : Belgium, Czechia

EU representative : Obelis s.a. (Belgium)

14 categories, 28 models including 28 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit2 refs98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II3 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	PowerPrep™ Pathogen NA Extraction Kit EXP2 refs PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 PowerPrep™ Viral NA Extraction Kit EXP2 refs PowerPrep™ Whole blood NA Extraction Kit EXP2 refs	A IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.098/79 PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit98/79 PowerChek™ SARS-CoV-2 Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	PowerChek™ 18 RV Panel Kit98/79 PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit98/79 PowerChek™ RSV A & B/HMV Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	PowerChek™ 20 Bacterial Panel Kit98/79 PowerChek™ Adeno / Astro / Rota Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.198/79 PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Measles - NA reagents	W0105040704	PowerChek™ Measles virus Real-time PCR Kit Ver.1.02 refs98/79 PowerChek™ MeV / MeVA Multiplex Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ2 refs98/79 PowerChek™ STI Multiplex Real-time PCR KitⅡ2 refs98/79	– 98/79	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	PowerEXP™ 48LH	A IVDR	EUDAMED record Report an error
Mumps / parotitis - NA reagents	W0105040804	PowerChek™ Mumps Real-time PCR Kit Ver.1.198/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	PowerChek™ MTB/NTM Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	PowerChek™ Salmonella Triplex Real-time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error

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