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SeraSpot® Anti-Borrelia IgM

Sera Spot® Anti-Borrelia IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301833
Basic UDI-DI: 4099466SP018MVU
Reference: SP-018 M-S6
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:02

Manufacturer products View details

SeraSpot® Anti-Borrelia IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301819
Basic UDI-DI: 4099466SP018GVG
Reference: SP-018 G-S6
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:02

Manufacturer products View details

RealTime

ABBOTT REALTIME CT/NG

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999001442
Basic UDI-DI: 0884999RTG02288E
Reference: 2G28-80
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 24.09.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Neisseria meningitidis Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277341
Basic UDI-DI: 868499827PCR113YH
Reference: CFP113P50
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

ChainFor™

Strep B qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034576
Basic UDI-DI: 868511580PCR111G8
Reference: CFP111P25
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

ChainFor™

LYO04WS24

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031414
Basic UDI-DI: 868354825PCR04NH
Reference: CFP04P25
EMDN: W0105011003
EMDN description: SALMONELLA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

LyoSens™

Lyme Disease qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259073
Basic UDI-DI: 868511580PCR67JS
Reference: LYO67WS24
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

01220000260054

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260054
Basic UDI-DI: 122000026NATCDIHV
Reference: NATCDI-6MC-IVD
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260023

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260023
Basic UDI-DI: 122000026NATCTM4
Reference: NATCT(434)-6MC-IVD
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

GSD01-1600-5C

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD0116005C0
Basic UDI-DI: B-B350GSD0116005C0
Reference: GSD01-1600-5C
EMDN: W0105010399
EMDN description: SYPHILIS REAGENTS OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260030

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260030
Basic UDI-DI: 122000026NATNGMB
Reference: NATNG-6MC-IVD
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260047

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260047
Basic UDI-DI: 122000026NATCTNGR4
Reference: NATCTNGNEG-6MC-IVD
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260146

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260146
Basic UDI-DI: 122000026NATSAGKY
Reference: NATSAG-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260153

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260153
Basic UDI-DI: 122000026NATLACJM
Reference: NATLAC-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260207

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260207
Basic UDI-DI: 122000026NATMRSAT3
Reference: NATMRSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260214

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260214
Basic UDI-DI: 122000026NATMSSETG
Reference: NATMSSE-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260221

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260221
Basic UDI-DI: 122000026NATMSSAT8
Reference: NATMSSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Neisseria meningitidis Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277334
Basic UDI-DI: 868499827PCR113YH
Reference: CFP113P25
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 18:48

Manufacturer products View details

ChainFor™

H. influenzae/N. meningitidis/S. pneumoniae Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034637
Basic UDI-DI: 868511580PCR142GK
Reference: CFP142P25
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 18:47

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the market

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258823
Basic UDI-DI: 868511580PCR28JG
Reference: LYO28WS24
EMDN: W0105011503
EMDN description: E. COLI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 18:11

Manufacturer products View details