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52 device results listed.

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Anti-SSA 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: 06975424225695
Basic UDI-DI: B-06975424225695
Reference: DL244701C
EMDN: W0102100112
EMDN description: SS-A
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

Anti-Ro52 Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224025
Basic UDI-DI: B-06975424224025
Reference: CL30362EN
EMDN: W0102100112
EMDN description: SS-A
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-SSA Assay Kit (Fluorescence Immunoassay)

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223943
Basic UDI-DI: B-06975424223943
Reference: DL244702
EMDN: W0102100112
EMDN description: SS-A
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-SSA Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424221802
Basic UDI-DI: B-06975424221802
Reference: 20T
EMDN: W0102100112
EMDN description: SS-A
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-Ro52 Antibody 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: 06975424220119
Basic UDI-DI: B-06975424220119
Reference: 100 tests/kit
EMDN: W0102100112
EMDN description: SS-A
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-SSA 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: 06975424220027
Basic UDI-DI: B-06975424220027
Reference: 100 tests/kit
EMDN: W0102100112
EMDN description: SS-A
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-SS-A IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761066
Basic UDI-DI: B-06975070761066
Reference: 18105001
EMDN: W0102100112
EMDN description: SS-A
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

SS-B/La-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004399
Basic UDI-DI: B-04049325004399
Reference: RE75241
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

SS-A/Ro-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004382
Basic UDI-DI: B-04049325004382
Reference: RE75231
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

SAA Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071560B5R9
Basic UDI-DI: B-0000128071560B5R9
Reference: HWTS-OT112
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS SS-A

CHORUSSSA

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: 08033891323189
Basic UDI-DI: 803389132CHORUSSSA00BW
Reference: 86018
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

EliA Ro52 Well

EliA Ro52

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015576
Basic UDI-DI: 7333066BUDI0104LT
Reference: 14-5598-01
EMDN: W0102100112
EMDN description: SS-A
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

EliA Ro60 Well

EliA Ro60

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015545
Basic UDI-DI: 7333066BUDI0088MN
Reference: 14-5525-01
EMDN: W0102100112
EMDN description: SS-A
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

EliA Ro Well

EliA Ro

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014548
Basic UDI-DI: 7333066BUDI0073M9
Reference: 14-5503-01
EMDN: W0102100112
EMDN description: SS-A
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

06950617403012

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