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VIASURE Salmonella, Campylobacter & Y. enterocolitica 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: 08435440202349
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY106L
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:38

Manufacturer products View details

D-90089-RTGA

EliGene® STD GAR/URE/MYC RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90089-RTGA
Basic UDI-DI: B-90089-RTGA
Reference: 90089-RT
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 19:28

Manufacturer products View details

PCR-Box Resistance

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730763
Basic UDI-DI: B-09120127730763
Reference: 09120127730763
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Fungi 48rx-s

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730732
Basic UDI-DI: B-09120127730732
Reference: 09120127730732
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Bacteria 48rx-s

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730725
Basic UDI-DI: B-09120127730725
Reference: 09120127730725
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box IPC

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730114
Basic UDI-DI: B-09120127730114
Reference: 09120127730114
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Resistance

IVD generalIVDDNo longer on the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730107
Basic UDI-DI: B-09120127730107
Reference: 09120127730107
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Fungi

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730091
Basic UDI-DI: B-09120127730091
Reference: 09120127730091
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

PCR-Box Bacteria

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730084
Basic UDI-DI: B-09120127730084
Reference: 09120127730084
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

hybcell Pathogens DNA xB

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730077
Basic UDI-DI: B-09120127730077
Reference: 09120127730077
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

hybcell Fungi DNA xB

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730060
Basic UDI-DI: B-09120127730060
Reference: 09120127730060
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

hybcell Bacteria DNA xB

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730053
Basic UDI-DI: B-09120127730053
Reference: 09120127730053
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

RevoDx Haemophilus Ducreyi qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717905
Basic UDI-DI: B-08683079717905
Reference: IP202249-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

RevoDx Ureaplasma Parvum qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717882
Basic UDI-DI: B-08683079717882
Reference: IP202246-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

RevoDx Ureaplasma Urealytıcum qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717875
Basic UDI-DI: B-08683079717875
Reference: IP202245-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Mycoplasma Hominis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717868
Basic UDI-DI: B-08683079717868
Reference: IP202244-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Mycoplasma Genitalium qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717851
Basic UDI-DI: B-08683079717851
Reference: IP202243-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Chlamydia Trachomatis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717844
Basic UDI-DI: B-08683079717844
Reference: IP202242-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Neisseria Gonorrhoeae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717837
Basic UDI-DI: B-08683079717837
Reference: IP202241-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx VZV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717820
Basic UDI-DI: B-08683079717820
Reference: IP202240-100
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details