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74 device results listed.

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STANDARD™ Legionella Ag Control

C-LGN01G

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725630
Basic UDI-DI: 88001117IPCA02FA16WF
Reference: 10LEGC20
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Syphilis Control Module

IVDR_67_LLB_DUB-C_C_REAG_Syphilis Control Module

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414976686
Basic UDI-DI: 0405686900734VP
Reference: 10469593
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Control Legionella Urinary Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104210
Basic UDI-DI: 805677131160145
Reference: 311601
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® Control QuantiFERON®-TB Gold Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103299
Basic UDI-DI: B-08056771103299
Reference: 311011
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

IMMULITE H. pylori IgG Control Module

IVDR_67_LLB_DUB-C_B_REAG_H. pylori IgG Control Module

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414989907
Basic UDI-DI: 0405686901428VL
Reference: 10469596
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Control Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101196
Basic UDI-DI: B-08056771101196
Reference: 317021
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:31

Manufacturer products View details

70845357044098

8254

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357044098
Basic UDI-DI: 084535708254BD
Reference: [8254] QC Sets and Panels: Helix Elite™ Blood Culture Identification Control Panel (43 Targets)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042810

8206

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042810
Basic UDI-DI: 084535708206B2
Reference: [8206] QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042803

8238

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042803
Basic UDI-DI: 084535708238BF
Reference: [8238] QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Negative Control
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042735

8232

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042735
Basic UDI-DI: 084535708232B3
Reference: [8232] QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042728

8229

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042728
Basic UDI-DI: 084535708229BE
Reference: [8229] QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042711

8227

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042711
Basic UDI-DI: 084535708227BA
Reference: [8227] QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042704

8231

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042704
Basic UDI-DI: 084535708231AZ
Reference: [8231] QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041493

8219

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041493
Basic UDI-DI: 084535708219BB
Reference: [8219] QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041431

8181

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041431
Basic UDI-DI: 084535708181BB
Reference: [8181] QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041424

8180

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041424
Basic UDI-DI: 084535708180B9
Reference: [8180] QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041387

8203

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041387
Basic UDI-DI: 084535708203AU
Reference: [8203] QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041363

8191

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041363
Basic UDI-DI: 084535708191BE
Reference: [8191] QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041172

8187

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041172
Basic UDI-DI: 084535708187BP
Reference: [8187] QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042795

HE0055NS

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042795
Basic UDI-DI: 08453570HE0055NS2N
Reference: [HE0055NS] Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus epidermidis (MSSE)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details