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179 device results listed.

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Control Set for rapid SARS-CoV-2 PCR

Control set for rapid SARS-CoV-2 PCR

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670503736
Basic UDI-DI: B-03532670503736
Reference: 6150006
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

AFP/IGFBP-1 Positive control

AFP/IGFBP-1 positive control

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670503705
Basic UDI-DI: B-03532670503705
Reference: 6090002
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: -
Authorised representative: -
Last updated: 05.07.2026 16:38

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MALARIA Control

IVD generalIVDDOn the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670503729
Basic UDI-DI: B-03532670503729
Reference: 6120001
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

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Contrôle positif liquide IGFBP-1

IGFBP-1 positive control

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670503712
Basic UDI-DI: B-03532670503712
Reference: 6090001
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: -
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

H. Pylori positive control

PYLORI positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502562
Basic UDI-DI: B-03532670502562
Reference: 6030002
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

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NOROVIRUS GII positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502463
Basic UDI-DI: B-03532670502463
Reference: 6150002
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Norovirus GI Positive Control

NOROVIRUS GI positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502449
Basic UDI-DI: B-03532670502449
Reference: 6150001
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Contrôle Positif FOB

FOB positive Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670501633
Basic UDI-DI: B-03532670501633
Reference: 6110001
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

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Negative control swab

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670501602
Basic UDI-DI: B-03532670501602
Reference: 6060001
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

AMNIOQUICK Card BSX

AMNIOQUICK CARD BSX

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670103738
Basic UDI-DI: B-03532670103738
Reference: 1090005_BSX_C
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

AMNIOQUICK DUO+

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670103714
Basic UDI-DI: B-03532670103714
Reference: 1090004_C
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

AMNIOQUICK CARD

AMNIOQUICK CARD (+ controls)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670103691
Basic UDI-DI: B-03532670103691
Reference: 1090005_C
EMDN: W0102060405
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

AMNIOQUICK

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670103684
Basic UDI-DI: B-03532670103684
Reference: 1090003_C
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Ksmart D-DIMER + Controls

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102823
Basic UDI-DI: B-03532670102823
Reference: 1050003_C
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Ksmart CRP + Controls

KSMART CRP + Controls

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102786
Basic UDI-DI: B-03532670102786
Reference: 1040012_C
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Ksmart CRP

KSMART CRP

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102755
Basic UDI-DI: B-03532670102755
Reference: 1040012
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Ksmart D-DIMER

KSMART D-DIMER

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102700
Basic UDI-DI: B-03532670102700
Reference: 1050003
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

BIOSYNEX AMPLIQUICK Respiratory Duplex

BIOSYNEX AMPLIQUICK Respiratory duplex

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102632
Basic UDI-DI: B-03532670102632
Reference: 3150076_SEC02
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

BIOSYNEX AMPLIQUICK Respiratory Duplex

BIOSYNEX AMPLIQUICK Respiratory duplex

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102625
Basic UDI-DI: B-03532670102625
Reference: 3150076_SEC01
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

TETANOTOP BSX

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670101574
Basic UDI-DI: B-03532670101574
Reference: 1030016_BSX
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details