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142 device results listed.

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SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method))

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349RQ005MB
Basic UDI-DI: B-CNMF000054349RQ005MB
Reference: RQ005
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-808155-1BE

SARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808155-1BE
Basic UDI-DI: B-808155-1BE
Reference: 808155-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808152-1AX

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808152-1AX
Basic UDI-DI: B-808152-1AX
Reference: 808152-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

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™ 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

RIDA®Plex Viral and Syphilis 12 well Step 1

RIDA®Plex Viral and Syphilis 12

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006852
Basic UDI-DI: B-09343044006852
Reference: 87095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral and Syphilis 12 well Step 2

RIDA®Plex Viral and Syphilis 12 well

IVD Annex II List BIVDDOn the marketReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006845
Basic UDI-DI: B-09343044006845
Reference: 87095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 8 well Step 1

RIDA®Plex Viral 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006586
Basic UDI-DI: B-09343044006586
Reference: 27093S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 8 well Step 2

RIDA®Plex Viral 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006579
Basic UDI-DI: B-09343044006579
Reference: 27093P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 12 well Step 1

RIDA®Plex Viral 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006562
Basic UDI-DI: B-09343044006562
Reference: 27095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 12 well Step 2

RIDA®Plex Viral 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006555
Basic UDI-DI: B-09343044006555
Reference: 27095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 1

RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006548
Basic UDI-DI: B-09343044006548
Reference: 27091S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 2

RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006531
Basic UDI-DI: B-09343044006531
Reference: 27091P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Viral and Syphilis 12-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004926
Basic UDI-DI: B-09343044004926
Reference: 87095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Viral and Syphilis 12-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004919
Basic UDI-DI: B-09343044004919
Reference: 87095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

09343044002724

Step 1 tubes for Viral Panel 12-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002724
Basic UDI-DI: B-09343044002724
Reference: 27095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

09343044002717

Step 2 Plates for Viral Panel 12-well

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002717
Basic UDI-DI: B-09343044002717
Reference: 27095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Viral 8-well

Step 1 tubes for Viral 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001932
Basic UDI-DI: B-09343044001932
Reference: 27093S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details