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36 device results listed.

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FR077-FluHunter-Human swine flu H1N1 (Ready to use Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430133
Basic UDI-DI: B-04262420430133
Reference: FR077
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR024-Human Herpes Simplex Virus 1 & 2 -Multiplex (Ready to use Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430256
Basic UDI-DI: B-04262420430256
Reference: FR024
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR074-Dengue Fever Virus -(Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430195
Basic UDI-DI: B-04262420430195
Reference: FR074
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430102
Basic UDI-DI: B-04262420430102
Reference: FR006
EMDN: W0105040515
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR325-Zika Virus-Single Check (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430072
Basic UDI-DI: B-04262420430072
Reference: FR325
EMDN: W0105040531
EMDN description: ZIKA VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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D0007-DNA Positive Control for Leptospira

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430034
Basic UDI-DI: B-04262420430034
Reference: D0007
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR004-Bordetella pertussis (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430027
Basic UDI-DI: B-04262420430027
Reference: FR004
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430003
Basic UDI-DI: B-04262420430003
Reference: FR013a
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

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FR799

FR799-Identification of human specific ß-Actin

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430010
Basic UDI-DI: 426242043GEN222SR
Reference: FR799
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 06:29

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STEM35-ELISA Washing Buffer

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420431062
Basic UDI-DI: 426242043ELISA2L
Reference: STEM35
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

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STEM33-ELISA Coating Buffer

IVD Class AIVDR 2017/746On the marketDirect markingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430850
Basic UDI-DI: 426242043STEM9E
Reference: STEM33
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430829
Basic UDI-DI: 426242043DNARNA25
Reference: SB0179
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

SB0079-Genekam Universal RNA-Isolation Kit (INT)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430799
Basic UDI-DI: 426242043RNAISO7R
Reference: SB0079
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

SB0001-Genekam Universal DNA-Isolation Kit (INT)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430706
Basic UDI-DI: 426242043DNAISO23
Reference: SB0001
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430225
Basic UDI-DI: 426242043GEN111SF
Reference: FR118
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

FR166-Yellow Fever Virus -(Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430041
Basic UDI-DI: B-04262420430041
Reference: FR166
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:56

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