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48 device results listed.

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VIASURE Group A Streptococcus Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217091
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS112LE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217107
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS112HE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217114
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113LE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217121
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS113HE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217169
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS196TE
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:49

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217138
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS101E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217145
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS136E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

VIASURE Group A Streptococcus Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217152
Basic UDI-DI: 84354402_MDXRESPB_GAS4V
Reference: VS-GAS172E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:48

Manufacturer products View details

Group A Streptococcus (GAS) 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: 06955792735576
Basic UDI-DI: B-06955792735576
Reference: S3260E-48
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus (GAS) 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: 06955792735569
Basic UDI-DI: B-06955792735569
Reference: S3260E-24
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Strep A

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570091
Basic UDI-DI: B-04719878570091
Reference: PCRAE0107
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AGAS01P6WQ

AGAS01-AOG48E; AGAS01D-AOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AGAS01P6WQ
Basic UDI-DI: B-69509960AGAS01P6WQ
Reference: AGAS01-AOG48E; AGAS01D-AOG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNVC-CED-03X6

Beta-haemolytic Group A Streptococcus Nucleic Acid Kit (Fluorescent PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Henan Vacure Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023292
UDI-DI: D-TD-HNVC-CED-03X6
Basic UDI-DI: B-TD-HNVC-CED-03X6
Reference: /
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002RGAS01JKST

RGAS01-AHG5E/ RGAS01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002RGAS01JKST
Basic UDI-DI: B-81649002RGAS01JKST
Reference: RGAS01-AHG5E/ RGAS01-AHG25E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AGAS01BNG6

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AGAS01BNG6
Basic UDI-DI: B-81649002AGAS01BNG6
Reference: AGAS01-AHG48E; AGAS01D-AHG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AGAS01DATP8

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AGAS01DATP8
Basic UDI-DI: B-81649002AGAS01DATP8
Reference: AGAS01-AHG48E; AGAS01D-AHG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA Strep A PCR Test (4x8)

300032

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953091
Basic UDI-DI: B-08885013953091
Reference: 300032
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Strep A qPCR Kit

LYO87WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115803535
Basic UDI-DI: B-08685115803535
Reference: LYO87
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RevoDx Streptococcus pyogenes qPCR Kit

RevoDx Streptococcus pyogenes qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212571
Basic UDI-DI: B-08684387212571
Reference: IP202313-100
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Streptococcus pyogenes qPCR Kit

RevoDx Streptococcus pyogenes qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212564
Basic UDI-DI: B-08684387212564
Reference: IP202313-25
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details