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187 device results listed.

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QUANTA Flash

QUANTA Flash® Circulating Calprotectin Controls

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000109
Basic UDI-DI: B-00195126000109
Reference: 701367
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Circulating Calprotectin Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000093
Basic UDI-DI: B-00195126000093
Reference: 701366
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Circulating Calprotectin Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000086
Basic UDI-DI: B-00195126000086
Reference: 701365
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® System Rinse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041157
Basic UDI-DI: 84307930411573H
Reference: AC1004
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Optical Cleaning Solution

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041140
Basic UDI-DI: 84307930411402Y
Reference: AC1003
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Optical Control Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041133
Basic UDI-DI: 843079304113333
Reference: AC1002
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Optical Calibrator Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041126
Basic UDI-DI: 843079304112636
Reference: AC1001
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgM Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040914
Basic UDI-DI: 84307930409143Y
Reference: 725142
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgM Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040907
Basic UDI-DI: 843079304090743
Reference: 725141
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgM Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040853
Basic UDI-DI: 843079304085345
Reference: 725140
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgG Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040778
Basic UDI-DI: 84307930407784G
Reference: 725102
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgG Calibrators

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040761
Basic UDI-DI: 84307930407613X
Reference: 725101
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® APS IgG Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040716
Basic UDI-DI: 84307930407163S
Reference: 725100
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva Instrument System Cuvettes

Instrument System Cuvettes

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000741
Basic UDI-DI: 84307930458034R
Reference: AC1005
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Multi-Analyte Instrument

AP5000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426951307227
Basic UDI-DI: 84269513072276Z
Reference: AP5000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 IFA

VS3002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865131
Basic UDI-DI: 84269508651319P
Reference: VS3002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA + Incubator

VS3000i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865100
Basic UDI-DI: 84269508651009C
Reference: VS3000i
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA

VS3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865094
Basic UDI-DI: 8426950865094AA
Reference: VS3000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA View® AUTOLoader

ADLR1000

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950643708
Basic UDI-DI: 84269506437088U
Reference: ADLR1000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Reagents

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627692
Basic UDI-DI: 84269506276929C
Reference: 701135
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details