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14 device results listed.

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04260154636104

Secretory IgA ELISA (96 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154636104
Basic UDI-DI: B-04260154636104
Reference: IC6100
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details

04260154636111

Secretory IgA ELISA (960 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: ImmuChrom GmbH
Manufacturer SRN: DE-MF-000033427
UDI-DI: 04260154636111
Basic UDI-DI: B-04260154636111
Reference: IC6110
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:37

Manufacturer products View details

AESKUBLOTS® Gluten Related Disorders IgG

AESKUBLOTS® Gluten Related Disorders

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289511902
Basic UDI-DI: B-04250289511902
Reference: 401006
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:59

Manufacturer products View details

AESKUBLOTS® Gluten Related Disorders IgA

AESKUBLOTS® Gluten Related Disorders

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289511278
Basic UDI-DI: B-04250289511278
Reference: 401005
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

Membranous Nephropathy Detection Kit

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangxi CellGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055358
UDI-DI: 06977846952395
Basic UDI-DI: B-06977846952395
Reference: E021700103
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Membranous Nephropathy Detection Kit

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangxi CellGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055358
UDI-DI: 06977846952388
Basic UDI-DI: B-06977846952388
Reference: E021700102
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Membranous Nephropathy Detection Kit

100tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangxi CellGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055358
UDI-DI: 06977846952371
Basic UDI-DI: B-06977846952371
Reference: E021700101
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Serum Amyloid A Test Card

1M24C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963717016
Basic UDI-DI: B-06921963717016
Reference: 1M24C2
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

RF Latex

OSR61105

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010966
Basic UDI-DI: 150995901OSR61105SJ
Reference: OSR61105
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

nAbCyte Anti-AAVRh74var HB-FE Assay

nAbCyte Anti-AAVRh74var HB-FE Assay 81-Test Device Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesProfessional testingSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-AntiSpark100nAbAssay8B
Basic UDI-DI: B-AntiSpark100nAbAssay8B
Reference: Anti-Spark 100 nAb Assay
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-AAv9 nAb

Anti-AAV9 nAb Assay

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-Anti-AAV9nAbAssayNS
Basic UDI-DI: B-Anti-AAV9nAbAssayNS
Reference: Anti-AAV9 nAb
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-AAV6 nAb Assay

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitMicrobial substancesSingle useSterile

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-Anti-AAV6nAbAssayLM
Basic UDI-DI: B-Anti-AAV6nAbAssayLM
Reference: Anti-AAV6 nAb Assay
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 12.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

IgE Rapid Test Device (whole blood/serum/plasma)

D020501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753472927
Basic UDI-DI: B-06976753472927
Reference: D020501D
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565455

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565455
Basic UDI-DI: B-06974541565455
Reference: ICA2230
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details