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465 device results listed.

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Anti-Jo-1 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: 06975424220065
Basic UDI-DI: B-06975424220065
Reference: 100 tests/kit
EMDN: W0102100108
EMDN description: JO-1
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-CENP 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: 06975424220058
Basic UDI-DI: B-06975424220058
Reference: 100 tests/kit
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
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-PM-Scl 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: 06975424220041
Basic UDI-DI: B-06975424220041
Reference: 100 tests/kit
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
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

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

Anti-Sm Antibody IgG 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: 06975424220010
Basic UDI-DI: B-06975424220010
Reference: 100 tests/kit
EMDN: W0102100111
EMDN description: SM
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

ANA Screening 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: 06975424220003
Basic UDI-DI: B-06975424220003
Reference: 100 tests/kit
EMDN: W0102100101
EMDN description: ANA SCREENING
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

System Wash

350mL×1, 350mL×4, 5L×1, 10L×1

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424228092
Basic UDI-DI: 697542422SystemWashZ2
Reference: 350mL×4
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescent Substrate

50mL×1,100mL×1,200mL×1, 500mL×1, 1L×1

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424228085
Basic UDI-DI: 697542422SUBSTRATECT
Reference: 100mL×1
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

DL300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223219
Basic UDI-DI: 697542422Fluorescence2L
Reference: DL300
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Free T4 CLIA Assay Kit