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142 device results listed.

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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

Step 1 tubes for Respiratory Pathogens 24-well

Respiratory Pathogens 24-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003615
Basic UDI-DI: B-09343044003615
Reference: 80617S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
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

Step 2 Plates for Respiratory Pathogens 24-well

Respiratory Pathogens 24-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003608
Basic UDI-DI: B-09343044003608
Reference: 80617P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
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

Step 1 tubes for Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002861
Basic UDI-DI: B-09343044002861
Reference: 27123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Step 2 Plates for Urinogenital and Resistance 12 well

Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002854
Basic UDI-DI: B-09343044002854
Reference: 27123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

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

Step 1 tubes for Urinogenital (8-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002229
Basic UDI-DI: B-09343044002229
Reference: 27113S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Step 2 Plates for Urinogenital (8-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002212
Basic UDI-DI: B-09343044002212
Reference: 27113P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Step 1 tubes for STI (16-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002120
Basic UDI-DI: B-09343044002120
Reference: 27112S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Step 2 Plates for STI (16-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002113
Basic UDI-DI: B-09343044002113
Reference: 27112P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Synthetic Positive Controls for CSF

IVD Annex II List BIVDDOn the marketProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002090
Basic UDI-DI: B-09343044002090
Reference: 91081
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

09343044002083

Synthetic Positive Controls for Atypical Pneumonia

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002083
Basic UDI-DI: B-09343044002083
Reference: 91071
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
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

Step 1 tubes for 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: 09343044001710
Basic UDI-DI: B-09343044001710
Reference: 27091S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001703
Basic UDI-DI: B-09343044001703
Reference: 27091P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Viral CSF (8-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001673
Basic UDI-DI: B-09343044001673
Reference: 27092S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Viral CSF (8-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001666
Basic UDI-DI: B-09343044001666
Reference: 27092P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Pneumonia (16-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001611
Basic UDI-DI: B-09343044001611
Reference: 20631S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Pneumonia (16-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001604
Basic UDI-DI: B-09343044001604
Reference: 20631P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogens B 16-well

Step 1 tubes for Respiratory Pathogens B 16-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044001451
Basic UDI-DI: B-09343044001451
Reference: 20612S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details