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59 device results listed.

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Anti-Ro52 Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224629
Basic UDI-DI: B-06975424224629
Reference: CL30361E
EMDN: W0102100112
EMDN description: SS-A
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ro52 Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224612
Basic UDI-DI: B-06975424224612
Reference: CL20361E
EMDN: W0102100112
EMDN description: SS-A
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSA CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224438
Basic UDI-DI: B-06975424224438
Reference: CL30131E
EMDN: W0102100112
EMDN description: SS-A
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSA CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224421
Basic UDI-DI: B-06975424224421
Reference: CL20131E
EMDN: W0102100112
EMDN description: SS-A
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

IDS SS-A/Ro 60 kDa

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693814
Basic UDI-DI: B-05060169693814
Reference: IS-AI1104
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS SS-A/Ro 52 kDa

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693807
Basic UDI-DI: B-05060169693807
Reference: IS-AI1103
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS SS-A/Ro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693791
Basic UDI-DI: B-05060169693791
Reference: IS-AI1102
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ro-52 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544788
Basic UDI-DI: 697015090000306HB
Reference: CMQ0805
EMDN: W0102100112
EMDN description: SS-A
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-A/Ro IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544689
Basic UDI-DI: 697015090000305H9
Reference: CMQ0705
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ro-52 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544764
Basic UDI-DI: 697015090000306HB
Reference: CMQ0803
EMDN: W0102100112
EMDN description: SS-A
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-A/Ro IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544665
Basic UDI-DI: 697015090000305H9
Reference: CMQ0703
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiverDot Granular12 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681824
Basic UDI-DI: 542502368BDDGRANULARDB
Reference: GR12DIV-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Granular12 IgG

BlueDot Granular

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680902
Basic UDI-DI: 542502368BDGRANULARQV
Reference: GR12D-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

SS-A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680073
Basic UDI-DI: B-04260158680073
Reference: 10107
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 25.07.2026 17:31

Manufacturer products View details

AESKULISA® SS-A-52

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500517
Basic UDI-DI: B-04250289500517
Reference: 3109
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® SS-A-60

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500500
Basic UDI-DI: B-04250289500500
Reference: 3108
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® SS-A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500494
Basic UDI-DI: B-04250289500494
Reference: 3107
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

D-IM4415257K5

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4415257K5
Basic UDI-DI: B-IM4415257K5
Reference: IM4415257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4414257JW

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4414257JW
Basic UDI-DI: B-IM4414257JW
Reference: IM4414257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411257J9

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411257J9
Basic UDI-DI: B-IM4411257J9
Reference: IM4411257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details