Manufacturer

gerbion

GermanyLegal entities : gerbion GmbH & Co. KG

Markets : Germany

Approvals : EU – class A

24 categories, 71 models including 71 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
Respiratory tract infections - multiplex NA reagents	W0105070503	alphaCube MTB/NTM/MAC98/79 alphaCube PanLegionella98/79 diarellaMTB/NTM/MAC real time PCR98/79 diarellaPanLegionella real time PCR Kit TM98/79 respiraRNA 3.0 real time RT-PCR Kit98/79 7 others respiraScreen 1 real time RT-PCR Kit98/79 respiraScreen 2 real time RT-PCR Kit98/79 respiraScreen 8plex seqc real time RT-PCR98/79 SMD lead MTC/NTM/MAC98/79 SMD lead respiraRNA 3.098/79 SMD lead respiraScreen 198/79 SMD lead respiraScreen 8plex seqc98/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	alphaCube MRSA 3.098/79 alphaCube PVL-MRSA98/79 diarellaMRSA 3.0 TM real time PCR Kit98/79 diarellaMRSA seqc real time PCR98/79 diarellaPVL-MRSA real time PCR98/79 1 other SMD lead MRSA seqc98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	alphaCube Borrelia/Rickettsia98/79 alphaCube Ehrlichia98/79 diarellaBorrelia/Rickettsia real time PCR98/79 diarellaEhrlichia real time PCR Kit TM98/79 SMD lead Borrelia/Rickettsia98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	alphaCube gastroplexVirus PLUS 2.098/79 gastroplexVirus PLUS 2.0 real time RT-PCR Kit98/79 gastroplexVirus real time RT-PCR Kit98/79 SMD lead gastroplexVirus98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	alphaCube Bordetella98/79 diarellaBordetella real time PCR Kit98/79 SMD lead Bordetella98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	alphaCube C.difficile98/79 diarellaC.difficile real time PCR Kit98/79 SMD lead C. diff.98/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	alphaCube Entero 2.098/79 SMD lead EnteroRhino98/79 virellaEntero 2.0 TM real time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	alphaCube TBEV/WNV98/79 SMD lead TBEV/WNV98/79 virellaTBEV/WNV real time RT-PCR98/79	– 98/79	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	alphaCube BV-198/79 diarellaBV-1 real time PCR Kit98/79 SMD lead BV 198/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	alphaCube HSV/VZV98/79 SMD lead HSV/VZV98/79 virellaHSV/VZV real time PCR98/79	– 98/79	EUDAMED record Report an error
Pneumocystis - NA reagents	W0105060405	alphaCube P.jirovecii quant98/79 diarellaP.jirovecii quant real time PCR98/79 SMD lead P.jirovecii quant Screen seqc98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	NukEx Mag RNA/DNA3 refs NukEx Pure RNA/DNA2 refs NukEx Virus	A IVDR	EUDAMED record Report an error
Coxiella burnetii (q fever) - NA reagents	W0105011603	alphaCube Q-Fever98/79 diarella Q-Fever real time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Fsme virus - NA reagents	W0105040512	alphaCube TBE98/79 virellaTBE real time RT-PCR Kit TM98/79	– 98/79	EUDAMED record Report an error
Legionella detection by NA reagents	W0105010503	alphaCube Legionella98/79 diarellaLegionella real time PCR Kit TM98/79	– 98/79	EUDAMED record Report an error
Lyme detection by NA reagents	W0105010605	alphaCube Borrelia98/79 diarellaBorrelia real time PCR Kit TM98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	alphaCube MTB98/79 diarellaMTB real time PCR Kit98/79	– 98/79	EUDAMED record Report an error
Other parasitology - NA reagents	W0105050399	alphaCube Babesia98/79 diarellaBabesia real time PCR Kit TM98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	diarellaSTI-2 real time PCR Kit98/79 SMD lead STI 298/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	alphaCube Tropical Fever 198/79 virellaTropica 1 real time RT-PCR Kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	virellaNoro real time RT-PCR Kit TM98/79	– 98/79	EUDAMED record Report an error
Rickettsia - NA reagents	W0105011605	diarellaRickettsia real time PCR98/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	virellaWNV real time RT-PCR98/79	– 98/79	EUDAMED record Report an error

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