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14 device results listed.

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res3plex direct PCR

res1plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890280
Basic UDI-DI: 426075389fbc121TY
Reference: FBC121
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:49

Manufacturer products View details

LyoSens™

LYO35

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258465
Basic UDI-DI: 868511580PCR35JD
Reference: LYO35WS24
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

RevoDx Streptococcus pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717554
Basic UDI-DI: B-08683079717554
Reference: IP202214-100
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

06955792732438

Streptococcus Pneumoniae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732438
Basic UDI-DI: B-06955792732438
Reference: S3078E
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus Pneumoniae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732421
Basic UDI-DI: B-06955792732421
Reference: S3078E
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260153

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260153
Basic UDI-DI: 122000026NATERCK5
Reference: NATLAC-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 07:55

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260146

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260146
Basic UDI-DI: 122000026NATERCK5
Reference: NATSAG-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 07:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa037WQ94

Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa037WQ94
Basic UDI-DI: B-697994388Fa037WQ94
Reference: Fa037
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-40VW
Basic UDI-DI: B-CDX-70-01-40VW
Reference: CDX-70-01-40
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-70-01-40URA
Basic UDI-DI: B-CDX-70-01-40URA
Reference: CDX-70-01-40
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-70-01-20VQ
Basic UDI-DI: B-CDX-70-01-20VQ
Reference: CDX-70-01-20
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra S. pneumoniae Assay Kit

CDX-70

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-70-01-20UQY
Basic UDI-DI: B-CDX-70-01-20UQY
Reference: CDX-70-01-20
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

S. PneumoStrip

3.165.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773165WYH9
Basic UDI-DI: B-84295773165WYH9
Reference: 3.165.XXX.YY.ZZZ
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

RevoDx Streptococcus pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213295
Basic UDI-DI: B-08684387213295
Reference: IP202214-500
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:56

Manufacturer products View details