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308 device results listed.

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08435287146189

ANTI-KERATIN ANTIBODIES (AKA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287146189
Basic UDI-DI: B-08435287146189
Reference: 44618
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287146097

ANTI-ISLET CELL ANTIBODIES (AICA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287146097
Basic UDI-DI: B-08435287146097
Reference: 44609
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145748

ANTI-ADRENAL CORTEX ANTIBODIES (AACA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145748
Basic UDI-DI: B-08435287145748
Reference: 44574
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145724

ANTI-ISLET CELL ANTIBODIES (AICA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145724
Basic UDI-DI: B-08435287145724
Reference: 44572
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145618

ANTI-SKIN ANTIBODIES (ASA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145618
Basic UDI-DI: B-08435287145618
Reference: 44561
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145601

ANTI-SKIN ANTIBODIES (ASA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145601
Basic UDI-DI: B-08435287145601
Reference: 44560
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145175

ANTI-KERATIN ANTIBODIES (AKA)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145175
Basic UDI-DI: B-08435287145175
Reference: 44517
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144888

GLOMERULAR BASEMENT MEMBRANE ANTIBODIES (GBMA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144888
Basic UDI-DI: B-08435287144888
Reference: 44588
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287110586

ANTI-ADRENAL CORTEX ANTIBODIES (AACA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287110586
Basic UDI-DI: B-08435287110586
Reference: 44575
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:43

Manufacturer products View details

QUANTA Flash

QUANTA Flash® Intrinsic Factor Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793039970
Basic UDI-DI: B-08430793039970
Reference: 701358
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash GBM Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950584650
Basic UDI-DI: B-08426950584650
Reference: 701143
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

NOVA Lite® Rat Liver, Kidney, Stomach Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950545798
Basic UDI-DI: B-08426950545798
Reference: 704180
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® ASCA IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950514213
Basic UDI-DI: B-08426950514213
Reference: 708870
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® ASCA IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950514206
Basic UDI-DI: B-08426950514206
Reference: 708865
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

NOVA Lite® Rat Liver, Kidney, Stomach Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950514176
Basic UDI-DI: B-08426950514176
Reference: 704170
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® Chromatin ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950506355
Basic UDI-DI: B-08426950506355
Reference: 708710
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

08012992555682

ANTI-ISLET CELL ANTIBODIES (AICA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555682
Basic UDI-DI: B-08012992555682
Reference: 55568
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992555675

GLOMERULAR BASEMENT MEMBRANE ANTIBODIES (GBMA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555675
Basic UDI-DI: B-08012992555675
Reference: 55567
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992555651

ANTI-SKIN ANTIBODIES (ASA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555651
Basic UDI-DI: B-08012992555651
Reference: 55565
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

06975491761157

20-5 tests/ kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491761157
Basic UDI-DI: B-06975491761157
Reference: 20-5 tests/ kit
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details