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208 device results listed.

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Low-pass whole-genome aneuploidy Dx w1.0

Low-pass whole-genome aneuploidy Dx w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A538488V
Basic UDI-DI: B-USMF000023929A538488V
Reference: A53848
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test Plasma cfTNA Control

Oncomine™ Dx Express Test Plasma cfTNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A5083783
Basic UDI-DI: B-USMF000023929A5083783
Reference: A50837 (A52168)
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test NTC Control

Oncomine™ Dx Express Test NTC Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508367Z
Basic UDI-DI: B-USMF000023929A508367Z
Reference: A50836 (A52167, A52168)
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40010738W
Basic UDI-DI: B-USMF000023929A40010738W
Reference: A40010734
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test FFPE RNA Control

Oncomine™ Dx Express Test FFPE RNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508357X
Basic UDI-DI: B-USMF000023929A508357X
Reference: A50835 (A52167)
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test FFPE DNA Control

Oncomine™ Dx Express Test FFPE DNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A508347V
Basic UDI-DI: B-USMF000023929A508347V
Reference: A50834 (A52167)
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40004679G
Basic UDI-DI: B-USMF000023929A40004679G
Reference: A40004674
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

HIV-1 Genotyping Kit

A54401

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302018128
Basic UDI-DI: B-10190302018128
Reference: A54401
EMDN: W0105030108
EMDN description: HIV 1 GENOTYPING - NA REAGENTS
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 User Guides and Assay Definition File

Oncomine™ Dx Target Test User Guides and Assay Definition File, a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017763
Basic UDI-DI: B-10190302017763
Reference: A52639 (A49756)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
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

Ion Torrent™ Oncomine™ Dx Express Test Panel

Ion Torrent™ Oncomine™ Dx Express Test Panel, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017305
Basic UDI-DI: B-10190302017305
Reference: A50871 (A54103, A54103RR)
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

TaqPath™ COVID-19 Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302016674
Basic UDI-DI: B-10190302016674
Reference: 966116 (A51738)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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

TaqPath™ COVID-19 RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302016667
Basic UDI-DI: B-10190302016667
Reference: A51662 (A51738)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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

TaqPath™ 1-Step Multiplex Master Mix (No ROX)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302016650
Basic UDI-DI: B-10190302016650
Reference: A51735 (A51738)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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

TaqPath™ COVID-19, Flu A/B, RSV Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015707
Basic UDI-DI: B-10190302015707
Reference: 966124 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

TaqPath™ COVID-19, Flu A/B, RSV Assay Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015691
Basic UDI-DI: B-10190302015691
Reference: A49956 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

TaqPath™ 1-Step Multiplex Master Mix (no ROX)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015660
Basic UDI-DI: B-10190302015660
Reference: A49971 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

TaqPath™ 1-Step Multiplex Master Mix (No ROX)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015523
Basic UDI-DI: B-10190302015523
Reference: A48111 (A48067)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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

TaqPath™ COVID-19, Flu A/B, RSV Control Dilution Buffer

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015516
Basic UDI-DI: B-10190302015516
Reference: A49958 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

TaqPath™ COVID-19 Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015509
Basic UDI-DI: B-10190302015509
Reference: A48105 (A48067)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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

TaqPath™ COVID-19 RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015493
Basic UDI-DI: B-10190302015493
Reference: A48102 (A48067)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
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