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52 device results listed.

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GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907356
Basic UDI-DI: B-08809115907356
Reference: IFMR-20.02B006-ABI
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907349
Basic UDI-DI: B-08809115907349
Reference: IFMR-20.02B006-ABF
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSterile

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904355
Basic UDI-DI: B-08809115904355
Reference: IFMR-20.02B006-CFX
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABDR RealAmp Kit

IFMR-10

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900555
Basic UDI-DI: B-08809115900555
Reference: IFMR-10.02B020-ABI
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

Genvinset® HLA B57v5 48 tests

Genvinset® HLA B57v5

IVD Annex II List BIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942680
Basic UDI-DI: B-08437016942680
Reference: GVS-B5705-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® HLA B57v5 24 tests

Genvinset® HLA B57v5

IVD Annex II List BIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942673
Basic UDI-DI: B-08437016942673
Reference: GVS-B5705-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

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Gluten DQuick DResolution

RT-59v3_96

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910695
Basic UDI-DI: B-08057680910695
Reference: RT-59v3_96
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

Manufacturer products View details

Gluten DQuick Dresolution

RT-59v3

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910688
Basic UDI-DI: B-08057680910688
Reference: RT-59v3
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:35

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Duplicα Real Time HLA-B*5701 EZ Type Kit

EER052032

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910442
Basic UDI-DI: B-08057680910442
Reference: EER052032
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:33

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HLA-B27

RT-53

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910329
Basic UDI-DI: B-08057680910329
Reference: RT-53
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:33

Manufacturer products View details

06974858560174

Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560174
Basic UDI-DI: B-06974858560174
Reference: P118H
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974604720210

Human Leukocyte B site 5801 Gene Detection Kit(PCR-Fluorescence Method)

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
Manufacturer SRN: CN-MF-000036323
UDI-DI: 06974604720210
Basic UDI-DI: B-06974604720210
Reference: YZYMT-039-CE
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:01

Manufacturer products Authorised representative products Authorised representative actors View details

04049095160554

RIDA®GENE HLA-B27

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095160554
Basic UDI-DI: B-04049095160554
Reference: PY0205
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

FluoroType® HLA-B27 VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003013
Basic UDI-DI: B-04049055003013
Reference: 60896
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

HLAB27GUARD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820119
Basic UDI-DI: 376032282CGENHLAB27J6
Reference: AB0022
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

gb GENETIC HLA-B*27

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925732
Basic UDI-DI: 85952239000006X6
Reference: 3257-100
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:57

Manufacturer products View details

gb GENETIC HLA-B*27

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925718
Basic UDI-DI: 85952239000006X6
Reference: 3257-025
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:57

Manufacturer products View details

Genvinset® HLA Behçet v5 48 tests

Genvinset® HLA Behçet v5

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942666
Basic UDI-DI: 8437016942GVS-B5CF
Reference: GVS-B505-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:36

Manufacturer products View details

Genvinset® HLA Behçet v5 24 tests

Genvinset® HLA Behçet v5

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942659
Basic UDI-DI: 8437016942GVS-B5CF
Reference: GVS-B505-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:36

Manufacturer products View details

Genvinset® HLA B27v5 48 tests

Genvinset® HLA B27v5

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942642
Basic UDI-DI: 8437016942GVS-B27LX
Reference: GVS-B2705-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:35

Manufacturer products View details