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Tissue-Tek Genie® anti-CD71 Rabbit Monoclonal Antibody [EP232]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233007346
Basic UDI-DI: B-00615233007346
Reference: 8322-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

HPIV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941643
Basic UDI-DI: 868459503VMD151SC9Q
Reference: VMD151SC01
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:47

Manufacturer products View details

RapidFor™

VMD151SC

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039915
Basic UDI-DI: 868459503VMD151SC9Q
Reference: VMD151SC
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:47

Manufacturer products View details

Tissue-Tek Genie® anti-CD14 Rabbit Monoclonal Antibody [EP128]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233007339
Basic UDI-DI: B-00615233007339
Reference: 8321-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-NKX3-1 Rabbit Monoclonal Antibody [EP356]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233007322
Basic UDI-DI: B-00615233007322
Reference: 8320-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-WT1 Rabbit Monoclonal Antibody [EP122]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001740
Basic UDI-DI: B-00615233001740
Reference: 8340-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Vimentin Mouse Monoclonal Antibody [V9]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001733
Basic UDI-DI: B-00615233001733
Reference: 8336-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Napsin A Rabbit Monoclonal Antibody [EP205]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001696
Basic UDI-DI: B-00615233001696
Reference: 8331-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-PMS2 Rabbit Monoclonal Antibody [EP51]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001634
Basic UDI-DI: B-00615233001634
Reference: 8328-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MSH2 Rabbit Monoclonal Antibody [RED2]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001627
Basic UDI-DI: B-00615233001627
Reference: 8327-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MUM 1 Rabbit Monoclonal Antibody [EP190]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001665
Basic UDI-DI: B-00615233001665
Reference: 8329-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MSH6 Rabbit Monoclonal Antibody [EP49]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001597
Basic UDI-DI: B-00615233001597
Reference: 8326-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MLH1 Mouse Monoclonal Antibody [GM011]

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233001580
Basic UDI-DI: B-00615233001580
Reference: 8324-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 21.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

CA 15-3 AccuLite CLIA Kit - 96 wells

5675-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870022178
Basic UDI-DI: 081687002CA1535675S4
Reference: 5675-300A
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 21.09.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™

VMPO34

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250452
Basic UDI-DI: 868354825VMPO34EPP5
Reference: VMPO34EP
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:43

Manufacturer products View details

RapidFor™

IL-6 (FIA)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595038314
Basic UDI-DI: 868354825VMPO34EPP5
Reference: VMPO34ED
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:43

Manufacturer products View details

RapidFor™

VMD123

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259967
Basic UDI-DI: 868354825VMD123TD8K
Reference: VMD123TD
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:43

Manufacturer products View details

RapidFor™

VMD107

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257093
Basic UDI-DI: 868354825VMD107TD8R
Reference: VMD107TD
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:43

Manufacturer products View details

RapidFor™

VMD83

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548253590
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83SC
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details

RapidFor™

ADV Resp. Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277846
Basic UDI-DI: 868354825VMD83SC3M
Reference: VMD83TD
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:42

Manufacturer products View details