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SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915CD001LA98
Basic UDI-DI: B-5713915CD001LA98
Reference: 8015, 8010, 8079
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

PCR kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 5713915CD003LE9S
Basic UDI-DI: B-5713915CD003LE9S
Reference: 8213, 8214
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:40

Manufacturer products View details

601070050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989408
Basic UDI-DI: B-08908007989408
Reference: 601070050
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Norovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000981
Basic UDI-DI: B-07332940000981
Reference: GXNOV-CE-10
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

+ENTIPRSV61640_

RSV A, RSV B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRSV61640_
Basic UDI-DI: B-+ENTIPRSV61640_
Reference: PRSV6164
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPRSV61610Z

RSV A, RSV B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPRSV61610Z
Basic UDI-DI: B-+ENTIPRSV61610Z
Reference: PRSV6161
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIADVM0010DS0S

NovaLisa® Adenovirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVM0010DS0S
Basic UDI-DI: B-+ENTIADVM0010DS0S
Reference: ADVM0010DS
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIADVM00100U

NovaLisa® Adenovirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVM00100U
Basic UDI-DI: B-+ENTIADVM00100U
Reference: ADVM0010
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIADVG0010DS0M

NovaLisa® Adenovirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVG0010DS0M
Basic UDI-DI: B-+ENTIADVG0010DS0M
Reference: ADVG0010DS
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIADVG00100O

NovaLisa® Adenovirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVG00100O
Basic UDI-DI: B-+ENTIADVG00100O
Reference: ADVG0010
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIADVA0010DS0G

NovaLisa® Adenovirus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVA0010DS0G
Basic UDI-DI: B-+ENTIADVA0010DS0G
Reference: ADVA0010DS
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTI301134670L

Adenovirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134670L
Basic UDI-DI: B-+ENTI301134670L
Reference: 30113467
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134660K

Adenovirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134660K
Basic UDI-DI: B-+ENTI301134660K
Reference: 30113466
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301134650J

Adenovirus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134650J
Basic UDI-DI: B-+ENTI301134650J
Reference: 30113465
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit

VIASURE Human Herpes Virus 6, 7 & 8 Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440228899
Basic UDI-DI: 84354402_MDXIMMUN_HHV75
Reference: VS-HHV106LE
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

VIASURE Flu Typing II Real Time PCR Detection Kit

VIASURE Flu Typing II Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205746
Basic UDI-DI: 84354402_MDXRESP_HXNZ2
Reference: VS-HXN106L
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

VIASURE Chikungunya Virus Real Time PCR Detection Kit

VIASURE Chikungunya Virus Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440203643
Basic UDI-DI: 84354402_MDXVECTOR_CHIHM
Reference: VS-CHI106L
EMDN: W0105040525
EMDN description: CHIKUNGUNYA VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

ALINITY M BKV

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999050655
Basic UDI-DI: 0884999AMN0985YB
Reference: 09N85-070
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

ZDC-K-001

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Co-Diagnostics, Inc.
Manufacturer SRN: US-MF-000036425
UDI-DI: D-ZDC-K-0014D
Basic UDI-DI: B-ZDC-K-0014D
Reference: ZDC-K-001
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit

YJC70303NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJC70303NW-50T58
Basic UDI-DI: B-YJC70303NW-50T58
Reference: YJC70303NW-50T
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details