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VITEK® 2 AST-N422

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

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026625603
Basic UDI-DI: 357302BUDI000901TR
Reference: 543082
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

ETEST® Gepotidacin (GEP)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026625252
Basic UDI-DI: 357302BUDI002136TJ
Reference: 543064
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

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ETEST® Norfloxacin (NX)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026625023
Basic UDI-DI: 357302BUDI000820TQ
Reference: 543049
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

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ETEST® Nalidixic-acid (NA)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026625009
Basic UDI-DI: 357302BUDI000818U5
Reference: 543047
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® MBL Meropenem/Meropenem + EDTA (MP/MPI)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624989
Basic UDI-DI: 357302BUDI002028TE
Reference: 543045
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® Nitrofurantoin (NI)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624965
Basic UDI-DI: 357302BUDI000824TY
Reference: 543043
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® Streptomycin (SM)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624941
Basic UDI-DI: 357302BUDI000912TW
Reference: 543041
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® Mupirocin (MU)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624903
Basic UDI-DI: 357302BUDI000816TZ
Reference: 543037
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® MBL Imipenem/Imipenem + EDTA (IP/IPI)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624859
Basic UDI-DI: 357302BUDI002027TC
Reference: 543032
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® Ceftaroline (CPT)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624798
Basic UDI-DI: 357302BUDI000839UD
Reference: 543026
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® ESBL Cefepime/cefepime + clavulanic acid (PM/PML)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624750
Basic UDI-DI: 357302BUDI000834U3
Reference: 543022
EMDN: W0104080505
EMDN description: TARGETED RESISTANCE TESTS - ESBL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:00

Manufacturer products View details

ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)

IVD Class BIVDR 2017/746Not intended for EU marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624736
Basic UDI-DI: 357302BUDI000826U4
Reference: 543020
EMDN: W0104080505
EMDN description: TARGETED RESISTANCE TESTS - ESBL
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL)

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624712
Basic UDI-DI: 357302BUDI000828U8
Reference: 542962
EMDN: W0104080505
EMDN description: TARGETED RESISTANCE TESTS - ESBL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Imipenem/Relebactam (IPR)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624019
Basic UDI-DI: 357302BUDI002013SZ
Reference: 542988
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Cefixime (IX)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623944
Basic UDI-DI: 357302BUDI000771U4
Reference: 542981
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Meropenem/Vaborbactam (MEV)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623999
Basic UDI-DI: 357302BUDI002036TD
Reference: 542986
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Moxifloxacin (MX)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623968
Basic UDI-DI: 357302BUDI000792UC
Reference: 542983
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Aztreonam (AT)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623845
Basic UDI-DI: 357302BUDI000766UB
Reference: 542971
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623807
Basic UDI-DI: 357302BUDI000802TN
Reference: 542967
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

ETEST® Levofloxacin (LE)

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623784
Basic UDI-DI: 357302BUDI000788UM
Reference: 542965
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details