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+ENTIEIA-384003

Herpes Simplex Virus 1+2 IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-384003
Basic UDI-DI: B-+ENTIEIA-384003
Reference: EIA-3840
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEIA-38390B

Herpes Simplex Virus 1+2 IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-38390B
Basic UDI-DI: B-+ENTIEIA-38390B
Reference: EIA-3839
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

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+ENTIEIA-382304

Cytomegalovirus (CMV) IgM ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-382304
Basic UDI-DI: B-+ENTIEIA-382304
Reference: EIA-3823
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEIA-380807

Cytomegalovirus (CMV) IgG ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-380807
Basic UDI-DI: B-+ENTIEIA-380807
Reference: EIA-3808
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVM0150DS0Z

NovaLisa® Epstein-Barr Virus (VCA) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVM0150DS0Z
Basic UDI-DI: B-+ENTIEBVM0150DS0Z
Reference: EBVM0150DS
EMDN: W010504040104
EMDN description: EBV VCA IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVM01500.

NovaLisa® Epstein-Barr Virus (VCA) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVM01500.
Basic UDI-DI: B-+ENTIEBVM01500.
Reference: EBVM0150
EMDN: W010504040104
EMDN description: EBV VCA IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVG0580DS0-

NovaLisa® Epstein-Barr Virus (EBNA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVG0580DS0-
Basic UDI-DI: B-+ENTIEBVG0580DS0-
Reference: EBVG0580DS
EMDN: W010504040106
EMDN description: EBV EBNA IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVG05800_

NovaLisa® Epstein-Barr Virus (EBNA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVG05800_
Basic UDI-DI: B-+ENTIEBVG05800_
Reference: EBVG0580
EMDN: W010504040106
EMDN description: EBV EBNA IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVG00800X

NovaLisa® Epstein-Barr Virus (EA-D) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVG00800X
Basic UDI-DI: B-+ENTIEBVG00800X
Reference: EBVG0080
EMDN: W010504040108
EMDN description: EBV EA IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVA01500P

NovaLisa® Epstein-Barr Virus (VCA) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVA01500P
Basic UDI-DI: B-+ENTIEBVA01500P
Reference: EBVA0150
EMDN: W010504040199
EMDN description: EBV ANTIBODIES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVG0150DS0T

NovaLisa® Epstein-Barr Virus (VCA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVG0150DS0T
Basic UDI-DI: B-+ENTIEBVG0150DS0T
Reference: EBVG0150DS
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEBVG01500V

NovaLisa® Epstein-Barr Virus (VCA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEBVG01500V
Basic UDI-DI: B-+ENTIEBVG01500V
Reference: EBVG0150
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDVM0640DS0R

NovaLisa® Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDVM0640DS0R
Basic UDI-DI: B-+ENTIDVM0640DS0R
Reference: DVM0640DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDVM06400T

NovaLisa® Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDVM06400T
Basic UDI-DI: B-+ENTIDVM06400T
Reference: DVM0640
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDEVZVM04900Q

Varicella-Zoster Virus (VZV) IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDEVZVM04900Q
Basic UDI-DI: B-+ENTIDEVZVM04900Q
Reference: DEVZVM0490
EMDN: W0105040903
EMDN description: VARICELLA ZOSTER VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDEVZVG04900K

Varicella-Zoster Virus (VZV) IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDEVZVG04900K
Basic UDI-DI: B-+ENTIDEVZVG04900K
Reference: DEVZVG0490
EMDN: W0105040902
EMDN description: VARICELLA ZOSTER VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENG0120DS0K

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG0120DS0K
Basic UDI-DI: B-+ENTIDENG0120DS0K
Reference: DENG0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENG01200M

NovaLisa® Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENG01200M
Basic UDI-DI: B-+ENTIDENG01200M
Reference: DENG0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENM0120DS0Q

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM0120DS0Q
Basic UDI-DI: B-+ENTIDENM0120DS0Q
Reference: DENM0120DS
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDENM01200S

NovaLisa® Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENM01200S
Basic UDI-DI: B-+ENTIDENM01200S
Reference: DENM0120
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details