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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

D-10106010104029X2

FMR1 CGG PCR

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-10106010104029X2
Basic UDI-DI: B-10106010104029X2
Reference: 100 Tests/Kit
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Positive Controls for Haemochromatosis

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003547
Basic UDI-DI: B-09343044003547
Reference: 91171
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 1 Tubes for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002335
Basic UDI-DI: B-09343044002335
Reference: 23156S
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Haemochromatosis 8-well

Step 2 Plates for Haemochromatosis 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002328
Basic UDI-DI: B-09343044002328
Reference: 23156P
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors 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

Sentosa SQ Thyroid Cancer Panel (4x8)

690034