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52 device results listed.

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OzTGSO HLA MX11 Typing Kit

58010, 58011

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: TBG Biotechnology Corp.
Manufacturer SRN: TW-MF-000029664
UDI-DI: 04718050362028
Basic UDI-DI: 47180503600580107Z
Reference: 58010, 58011
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

04260224890658

HISTO TYPE Rainbow

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testing

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890658
Basic UDI-DI: 426022489HRTP01ACSC
Reference: 728220
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

Genvinset® HLA B51

Genvinset® HLA B51 24 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250097
Basic UDI-DI: 843661525GVS-B51N4
Reference: GVS-B51-24
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

Genvinset® HLA B51 48 test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08436615250103
Basic UDI-DI: 843661525GVS-B51N4
Reference: GVS-B51-48
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

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H-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen

H-Seq-LR-NGS.m4 Ref 021

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860230Z
Basic UDI-DI: ++G286LongRangeNGS7K
Reference: 021
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

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H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen

H-Seq-NGS, Ref 014

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860140Z
Basic UDI-DI: ++G286HSeqNGSP9
Reference: 014
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

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H-Seq-ABC Sequenzierungskit für 48 Typisierungen

H-Seq-ABC Ref 001

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860010V
Basic UDI-DI: ++G286HSeqABCKR
Reference: 001
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

geneMAP

geneMAP HLA-B*51 Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405B51RT50X7
Basic UDI-DI: B-TRMF000028405B51RT50X7
Reference: B51-RT50
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

geneMAP

geneMAP HLA-B*27 Detection Kit, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405B27RT50Y2
Basic UDI-DI: B-TRMF000028405B27RT50Y2
Reference: B27-RT50
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

Cowingene Human Leukocyte Antigen B27 Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HG01HG
Basic UDI-DI: B-HG01HG
Reference: HG01021X, HG01022X, HG01023W
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

HLA Typing NGS Panel

G2MHLA32001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MHLA32001JP
Basic UDI-DI: B-G2MHLA32001JP
Reference: G2MHLA32001-ill; G2MHLA32001-MG; G2MHLA32001-TF
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

HLA B27-Q Real Time PCR Kit

G2M801121

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M801121EL
Basic UDI-DI: B-G2M801121EL
Reference: G2M801121, G2M801121R
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-90085-RTFE

EliGene® CELIAC DQ PLUS RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90085-RTFE
Basic UDI-DI: B-90085-RTFE
Reference: 90085-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-90071-RTE7

EliGene® Coeliac 3.0 RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90071-RTE7
Basic UDI-DI: B-90071-RTE7
Reference: 90071-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

HLA B27 Strip

3.154.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773154WTGK
Basic UDI-DI: B-84295773154WTGK
Reference: 3.154.XXX.YY.ZZZ
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

CeliacStrip

3.152.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773152WPFZ
Basic UDI-DI: B-84295773152WPFZ
Reference: 3.152.XXX.YY.ZZZ
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

Truenat HLA-B27

601380025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139507
Basic UDI-DI: B-08908020139507
Reference: 601380025
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989842
Basic UDI-DI: B-08908007989842
Reference: 601380050
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989835
Basic UDI-DI: B-08908007989835
Reference: 601380020
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat HLA-B27

601380005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989828
Basic UDI-DI: B-08908007989828
Reference: 601380005, 601380020, 601380025, 601380050
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details