Manufacturer

Genekam

GermanyLegal entities : Genekam Biotechnology AG

Markets : Germany

Approvals : EU – class A

15 categories, 26 models including 26 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
IVD general use consumable devices - other	W0599	SB0001-Genekam Universal DNA-Isolation Kit (INT) SB0079-Genekam Universal RNA-Isolation Kit (INT) SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)	A IVDR	EUDAMED record Report an error
Leptospira - NA reagents	W0105011604	D0007-DNA Positive Control for Leptospira98/79 FR001-Leptospira pathogenic (Realtime PCR-Kit)98/79 K017a-Leptospira pathogenic (Ready to use PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Standards and calibrators for all infections/ NAT	W0105080908	FR118-Human specific DNA-Internal Control (Realtime PCR-Kit) FR799-Identification of human specific ß-Actin K025-Identification of human specific DNA98/79	A IVDR, 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	FR060-Fluhunter: Influenza A Virus (Ready to use Realtime PCR-Kit)98/79 FR077-FluHunter-Human swine flu H1N1 (Ready to use Realtime PCR-Kit)98/79 FR166-Yellow Fever Virus -(Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Avian influenza - NA reagents	W0105040515	D0046-cDNA positive-Control for Influenza Virus H598/79 FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Lyme detection by NA reagents	W0105010605	D0003-DNA-Positive Control for Borrrelia burgdorferi98/79 K740-Detection of Borrelia burgdorferi98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	K201-Plasmodium falciparum98/79 K404-Plasmodium vivax98/79	– 98/79	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	D0020-Ureaplasma urealyticum-Positive PCR-Control98/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	FR004-Bordetella pertussis (Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Brucella - NA reagents	W0105011601	K063-Brucella abortus-Ready to use PCR-Kit98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	FR074-Dengue Fever Virus -(Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	FR024-Human Herpes Simplex Virus 1 & 2 -Multiplex (Ready to use Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	FR325-Zika Virus-Single Check (Realtime PCR-Kit)98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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