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115 device results listed.

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RespiGUARD4plex

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820072
Basic UDI-DI: 376032282DINFSCFRRK
Reference: AB0024
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751871
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751864
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999052116
Basic UDI-DI: 0884999AMN0067WU
Reference: 09N79-082
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 25.06.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Influenza A+B Ag Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205148
Basic UDI-DI: B-06937339205148
Reference: VID36-08-011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Influenza A+B/RSV Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205056
Basic UDI-DI: B-06937339205056
Reference: VID111-01-011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

PlexPCR RespiVirus Positive Control

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000139
Basic UDI-DI: 9352224012010WA
Reference: 95002
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 21.06.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

PlexPCR RespiVirus (610)

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001051
Basic UDI-DI: 9352224012010WA
Reference: 1201192
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 21.06.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049345
Basic UDI-DI: 0884999AMN0979YG
Reference: 09N79-080
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 19.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570084
Basic UDI-DI: B-04719878570084
Reference: PCRAE0106
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.06.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304798
Basic UDI-DI: 89080153043B012MQ
Reference: 3B012
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 17.06.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304804
Basic UDI-DI: 89080153043B012MQ
Reference: 3B312
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 17.06.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

PlexPCR RespiVirus (LC480)

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001372
Basic UDI-DI: 9352224012010WA
Reference: 99011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: MedEnvoy Global BV
Last updated: 17.06.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCRÂ® Flu Panel with RSV detection Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304057
Basic UDI-DI: 89080153043B221N3
Reference: 3B221
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 17.06.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCRÂ® Flu Panel with RSV detection Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930047
Basic UDI-DI: 89080153043B221N3
Reference: 3B222
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 17.06.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details