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697 device results listed.

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Oncomine™ Solid Tumour DNA Kit (Part 2 of 2)

Oncomine™ Solid Tumour DNA Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302006866
Basic UDI-DI: B-10190302006866
Reference: A2676102 (A26761)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Solid Tumour DNA Kit (Part 1 of 2)

Oncomine™ Solid Tumour DNA Kit (Part 1 of 2), a part of Oncomine™ Solid Tumour Kits

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302006859
Basic UDI-DI: B-10190302006859
Reference: A2676101 (A26761)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ion Torrent™ Dx No Template Control Kit

Ion Torrent™ Dx No Template Control Kit, a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302006156
Basic UDI-DI: B-10190302006156
Reference: A32444 (A49756)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target RNA Control Kit

Oncomine™ Dx Target RNA Control Kit, a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302006064
Basic UDI-DI: B-10190302006064
Reference: A32443 (A49756)
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ Thyroid Cancer Panel (4x8)

690034

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956108
Basic UDI-DI: B-08885013956108
Reference: 690034
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ NSCLC Panel (4x8)

690010

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956061
Basic UDI-DI: B-08885013956061
Reference: 690010
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)

300755

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953947
Basic UDI-DI: B-08885013953947
Reference: 300755
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)

300753

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953930
Basic UDI-DI: B-08885013953930
Reference: 300753
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA NRAS PCR Test (4x8)

300086

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953190
Basic UDI-DI: B-08885013953190
Reference: 300086
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA KRAS PCR Test (4x8)

300083

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953183
Basic UDI-DI: B-08885013953183
Reference: 300083
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BRAF V600 PCR Test (4x8)

300003

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953176
Basic UDI-DI: B-08885013953176
Reference: 300003
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ONCOaccuPanel

NGB162V-060

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870458
Basic UDI-DI: B-08809539870458
Reference: NGB162V-060
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

SOLIDaccuTest DNA

NGB131V-096

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870281
Basic UDI-DI: B-08809539870281
Reference: NGB131V-096
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

SOLIDaccuTest DNA

NGB131V-048

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870267
Basic UDI-DI: B-08809539870267
Reference: NGB131V-048
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

HEMEaccuTest DNA

NGB121V-096

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870151
Basic UDI-DI: B-08809539870151
Reference: NGB121V-096
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

HEMEaccuTest DNA

NGB121V-048

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870137
Basic UDI-DI: B-08809539870137
Reference: NGB121V-048
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

MAF (16q23)/D16Z3

KBI-00116

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349358
Basic UDI-DI: B-08717973349358
Reference: KBI-00116
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

ESWR1 (22q12) Proximal - XL

KBI-XL019

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349259
Basic UDI-DI: B-08717973349259
Reference: KBI-XL019
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SS18 (18q11) Distal - XL

KBI-XL018

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349242
Basic UDI-DI: B-08717973349242
Reference: KBI-XL018
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

FUS (16p11) Proximal - XL

KBI-XL017

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 08717973349235
Basic UDI-DI: B-08717973349235
Reference: KBI-XL017
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details