54 results
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18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class C
×
HEPATITIS E VIRCLIA® IgM MONOTEST
Device
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·On the market·32 countries
AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL
Device
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·On the market·32 countries
NIPT-GeneSGKit CE-IVD 12 Reacciones
Device
EU IVDR
·
Eu Ivd Class C
·SISTEMAS GENOMICOS. S.L.·On the market·32 countries
ATK HPV
Device
EU IVDR
·
Eu Ivd Class C
·Arghavan Teb Kavian·On the market·3 countries
GONOCOCCAL ANTIGEN DETECTION
Device
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country
Chlamydia Antigen Rapid Test Kit
Device
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·3 countries
AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC125
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
AMPLIRUN® NEISSERIA GONORRHOEAE DNA CONTROL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC019
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC084
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC023
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
RTPCR016
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·2 devices
VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC112
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC079
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
MBC034
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device
VCM033
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Vircell, S.L·1 device