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Anti-SS-B 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: 06942359544887
Basic UDI-DI: 697015090000307HD
Reference: CMQ0905
EMDN: W0102100113
EMDN description: SS-B
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-B 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: 06942359544863
Basic UDI-DI: 697015090000307HD
Reference: CMQ0903
EMDN: W0102100113
EMDN description: SS-B
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

SS-B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680103
Basic UDI-DI: B-04260158680103
Reference: 10110
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: -
Last updated: 25.07.2026 17:31

Manufacturer products View details

AESKULISA® SS-B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500524
Basic UDI-DI: B-04250289500524
Reference: 3110
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

D-IM4409258KQ

Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409258KQ
Basic UDI-DI: B-IM4409258KQ
Reference: IM4409258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-B

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147193522
Basic UDI-DI: B-86060147193522
Reference: N705A24SSB
EMDN: W0102100113
EMDN description: SS-B
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® SS-B Reagents

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595786
Basic UDI-DI: B-08426950595786
Reference: 701153
EMDN: W0102100113
EMDN description: SS-B
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSB CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226944
Basic UDI-DI: B-06975424226944
Reference: CL30142EN
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSB CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226470
Basic UDI-DI: B-06975424226470
Reference: CL20142EN
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSB Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225701
Basic UDI-DI: B-06975424225701
Reference: DL244801C
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223950

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223950
Basic UDI-DI: B-06975424223950
Reference: DL244802
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSB Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424221819
Basic UDI-DI: B-06975424221819
Reference: 20T
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSB CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424220034
Basic UDI-DI: B-06975424220034
Reference: 100 tests/kit
EMDN: W0102100113
EMDN description: SS-B
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-SS-B/La IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769345
Basic UDI-DI: B-06975070769345
Reference: 14000725
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-SS-B/La IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761073
Basic UDI-DI: B-06975070761073
Reference: 18106001
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS SS-B

CHORUSSSB

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323202
Basic UDI-DI: 803389132CHORUSSSB00C3
Reference: 86024
EMDN: W0102100113
EMDN description: SS-B
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

EliA La Well

EliA La

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014555
Basic UDI-DI: 7333066BUDI0074MB
Reference: 14-5504-01
EMDN: W0102100113
EMDN description: SS-B
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

06950617402619

IM4402258 IM4403258 IM4409258 IM4407258

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402619
Basic UDI-DI: 69506174IM440258DV
Reference: IM4407258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402602

IM4402258 IM4403258 IM4409258 IM4407258

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402602
Basic UDI-DI: 69506174IM440258DV
Reference: IM4409258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

06950617402596

IM4402258 IM4403258 IM4409258 IM4407258

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617402596
Basic UDI-DI: 69506174IM440258DV
Reference: IM4403258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details