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304 device results listed.

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NGSgo®-MX11-3

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469369393
Basic UDI-DI: 871846936ngsgo-mx11-3ST
Reference: 7971864
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

08718469369386

NGSgo-MX6-1

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

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469369386
Basic UDI-DI: 871846936ngsgo-mx6-19E
Reference: 7971464
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

NGSgo®-AmpX v2 HLA-A, B, C, DRB1, DQB1, DPB1

NGSgo®-AmpX v2

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469369263
Basic UDI-DI: 871846936ngsgo-ampxv2F4
Reference: 7971462
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

NGSgo® Library Full Kit Library Preparation and Indexing Kit For Illumina – IndX plate I

NGSgo® Library Full Kit

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

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469368792
Basic UDI-DI: 871846936libraryfullkit79
Reference: 2842156
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

NGSgo®-AmpX v3 HLA-A, B, C, DRB1, DQB1, DPB1

NGSgo®-AmpX v3

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469366699
Basic UDI-DI: 871846936ngsgo-ampxv3F6
Reference: 7934462
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

NGSgo®-ProntoAmp

NGS-Pronto®

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469362905
Basic UDI-DI: 871846936prontoampBV
Reference: 9903613
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

NanoTYPE 24/11 CE

NanoTYPE

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781279
Basic UDI-DI: 599956578001TV
Reference: NT2411CE
EMDN: W01030499
EMDN description: TISSUE TYPING REAGENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 16:38

Manufacturer products View details

Streck Cell Preservative

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 10844509000843
Basic UDI-DI: 08445090CY93
Reference: 213350
EMDN: W01030406
EMDN description: LYMPHOCYTE STABILIZING MEDIA
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

Streck Cell Preservative

IVD Class ANot specifiedOn the marketReagent

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 10844509000850
Basic UDI-DI: 08445090CY93
Reference: 213358
EMDN: W01030406
EMDN description: LYMPHOCYTE STABILIZING MEDIA
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 11 HT HLA Typing Kit

MIA FORA NGS MFlex HLA Typing Kit & Software

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948636
Basic UDI-DI: 08500819481PAJ
Reference: SR-800-10534-1152
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 16.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQB1 Typing Kit

LinkSēq™ HLA Typing Kits

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

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025251
Basic UDI-DI: 081469502LNQHM
Reference: 1054C-ABS
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

SeCore™ A Locus Sequencing Kit

SeCore™ HLA Sequencing System

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

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695021697
Basic UDI-DI: 081469502SECGZ
Reference: 5300025
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen Negative Control Serum

C1qScreen™ C1q

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117016641
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-NC
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

LABType™ SSO Typing Test

RSSO1A

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

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117011042
Basic UDI-DI: 081211701SSOAZ
Reference: RSSO1A
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

H-Seq-DPB Sequenzierungskit für 48 Typisierungen

H-Seq-DPB Ref 015

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

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860150-
Basic UDI-DI: ++G286HSeqDPBMG
Reference: 015
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

H-Seq-DQB Sequenzierungskit für 48 Typisierungen

H-Seq-DQB Ref 008

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

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860080_
Basic UDI-DI: ++G286HSeqDQBMK
Reference: 008
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

H-Seq-DR Sequenzierungskit für 48Typisierungen

H-Seq-DR Ref 002

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

Manufacturer: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
Manufacturer SRN: DE-MF-000018980
UDI-DI: +G2860030X
Basic UDI-DI: ++G286HSeqDRHH
Reference: 002
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 20:22

Manufacturer products View details

MIA FORA NGS MFlex 11 HLA Typing Kit, 24 Test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948742
Basic UDI-DI: 08500819481PAJ
Reference: SR-800-10534-24
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 11 HLA Typing Kit, 96 Test

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948759
Basic UDI-DI: 08500819481PAJ
Reference: SR-800-10534-96
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 6 HT HLA Typing Kit

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948643
Basic UDI-DI: 08500819481PAJ
Reference: SR-800-10535-1152
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details