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186 device results listed.

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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-697994388Fa039WU9N

Streptococcus pneumoniae 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-697994388Fa039WU9N
Basic UDI-DI: B-697994388Fa039WU9N
Reference: Fa039
EMDN: W0105011102
EMDN description: STREPTOCOCCAL 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

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

D-697603130CGBS01ACKVM

CGBS01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CGBS01ACKVM
Basic UDI-DI: B-697603130CGBS01ACKVM
Reference: CGBS01A-AHG4E
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus pneumoniae antigen rapid test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312614
Basic UDI-DI: B-69743840312614
Reference: 3027401
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Device (Swab)

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309744
Basic UDI-DI: B-69743840309744
Reference: 3026201
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

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

BBL

BD BBL™ Streptocard™ Enzyme Test Latex B

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409571
Basic UDI-DI: 038290VFHRAXUWH4
Reference: 240957
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Enzyme Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409335
Basic UDI-DI: 038290OINNIEDIBW
Reference: 240933
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409311
Basic UDI-DI: 038290ZEIFIXSMG6
Reference: 240931
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex D

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409298
Basic UDI-DI: 038290ZMVGDGKALS
Reference: 240929
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex G

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409274
Basic UDI-DI: 038290OXAIXBYPJ4
Reference: 240927
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex C

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409267
Basic UDI-DI: 038290VIAUFMOAEB
Reference: 240926
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Extraction Reagents 1, 2 and 3

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409250
Basic UDI-DI: 038290PPRQIOIWMS
Reference: 240925
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Enzyme Extraction

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409243
Basic UDI-DI: 038290QRQTLGKVPL
Reference: 240924
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex B

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409229
Basic UDI-DI: 038290OGQXROZRMN
Reference: 240922
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Enzyme Test Latex A

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409588
Basic UDI-DI: 038290GYMSVFYGMT
Reference: 240958
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Enzyme Test Latex D

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409380
Basic UDI-DI: 038290MGGIBRZV8G
Reference: 240938
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

BBL

BD BBL™ Streptocard™ Acid Test Latex F

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409304
Basic UDI-DI: 038290LHRHITCLBL
Reference: 240930
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details