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371 device results listed.

Page 16 / 19

Anti-rRNP0 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: 06975424220102
Basic UDI-DI: B-06975424220102
Reference: 100 tests/kit
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN 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-PCNA 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: 06975424220096
Basic UDI-DI: B-06975424220096
Reference: 100 tests/kit
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
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-His 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: 06975424220089
Basic UDI-DI: B-06975424220089
Reference: 100 tests/kit
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-Nuc 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: 06975424220072
Basic UDI-DI: B-06975424220072
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 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Anti-Scl-70 Antibody CLIA Assay Kit

-

IVD generalNot specifiedOn the market

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226579
Basic UDI-DI: B-06975424226579
Reference: CL20402EN
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 18.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Free T4 CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222939
Basic UDI-DI: B-06975424222939
Reference: CL31062E
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Free T3 CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222922
Basic UDI-DI: B-06975424222922
Reference: CL31052E
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

TSH CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222915
Basic UDI-DI: B-06975424222915
Reference: CL31012E
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

T4 CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222908
Basic UDI-DI: B-06975424222908
Reference: CL31042E
EMDN: W01020406
EMDN description: T- UPTAKE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

T3 CLIA Assay Kit

-

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222892
Basic UDI-DI: B-06975424222892
Reference: CL31032E
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details