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682 device results listed.

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Oncomine™ Dx Target DNA Control v2.0 Kit

Oncomine™ Dx Target DNA Control v2.0 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: 10190302015134
Basic UDI-DI: B-10190302015134
Reference: A44913 (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 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test (DNA and RNA Panel)

Oncomine™ Dx Target Test (DNA and RNA Panel), a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302015103
Basic UDI-DI: B-10190302015103
Reference: A32441 (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 Diluent

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

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302014335
Basic UDI-DI: B-10190302014335
Reference: A38872 (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™ Solid Tumour Fusion Transcript Kit (Part 2 of 2)

Oncomine™ Solid Tumour Fusion Transcript 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: 10190302006880
Basic UDI-DI: B-10190302006880
Reference: A2676202 (A26762)
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 Fusion Transcript Kit (Part 1 of 2)

Oncomine™ Solid Tumour Fusion Transcript 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: 10190302006873
Basic UDI-DI: B-10190302006873
Reference: A2676201 (A26762)
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 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