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65 device results listed.

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LyoSens™

LYO02

IVD Class BIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258427
Basic UDI-DI: 868499827PCR02XD
Reference: LYO02WS24
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:46

Manufacturer products View details

HCPlex RSV PCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349141373
Basic UDI-DI: 697334914HS36LS
Reference: HS36-24
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

HCPlex RSV PCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349141380
Basic UDI-DI: 697334914HS36LS
Reference: HS36-48
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

HCPlex RSV PCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349141397
Basic UDI-DI: 697334914HS36LS
Reference: HS36-96
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: -
Authorised representative: Share info GmbH
Last updated: 21.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

RespiFinder® 2SMART

PF2600-2S

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327116197
Basic UDI-DI: B-08719327116197
Reference: PF2600-2S
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870798
Basic UDI-DI: B-06974081870798
Reference: RSV001
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx RSV qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717684
Basic UDI-DI: B-08683079717684
Reference: IP202231-100
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

06928103002032

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103002032
Basic UDI-DI: B-06928103002032
Reference: DA0203
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103002025

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103002025
Basic UDI-DI: B-06928103002025
Reference: DA0202
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103002018

Single tube, 10 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103002018
Basic UDI-DI: B-06928103002018
Reference: DA0201
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103002001

Single tube, 10 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103002001
Basic UDI-DI: B-06928103002001
Reference: DA0200
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE RSV A + B Real Time PCR Detection Kit