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173 device results listed.

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QUANTA Flash

QUANTA Flash® Ro52 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950596523
Basic UDI-DI: B-08426950596523
Reference: 701263
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® DFS70 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950581956
Basic UDI-DI: B-08426950581956
Reference: 701268
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® RNA Pol III ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950506362
Basic UDI-DI: B-08426950506362
Reference: 704555
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630068

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630068
Basic UDI-DI: B-06976043630068
Reference: 006
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630051

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630051
Basic UDI-DI: B-06976043630051
Reference: 005
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630044

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630044
Basic UDI-DI: B-06976043630044
Reference: 004
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-His 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: 06975424226999
Basic UDI-DI: B-06975424226999
Reference: CL30342EN
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 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-His 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: 06975424226524
Basic UDI-DI: B-06975424226524
Reference: CL20342EN
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 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

MDA5 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: 06975424225558
Basic UDI-DI: B-06975424225558
Reference: DL233401C
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 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06975424223837

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223837
Basic UDI-DI: B-06975424223837
Reference: DL233406
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 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

MDA5 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: 06975424223233
Basic UDI-DI: B-06975424223233
Reference: 20 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 22:38

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

Sharay Anti-α-Fodrin IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769987
Basic UDI-DI: B-06975070769987
Reference: 14000752
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-PCNA IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769406
Basic UDI-DI: B-06975070769406
Reference: 14000750
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-Ro52 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769383
Basic UDI-DI: B-06975070769383
Reference: 14000727
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-Myositis Antibody Profile IgG (CLIA)

Model 4: Sharay Anti-MDA5 lgG, 50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769284
Basic UDI-DI: B-06975070769284
Reference: 14000876
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-DFS70 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769185
Basic UDI-DI: B-06975070769185
Reference: 14000867
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-Endothelial Cell IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769178
Basic UDI-DI: B-06975070769178
Reference: 14000866
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
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-Myositis Antibody Profile IgG (CLIA)

Model 4: Sharay Anti-MDA5 lgG, 100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070768294
Basic UDI-DI: B-06975070768294
Reference: 14000715
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:47

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Bullous Dermatosis IgG (CLIA)

Model 5: BP230

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070768010
Basic UDI-DI: B-06975070768010
Reference: 14000688
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:47

Manufacturer products Authorised representative products Authorised representative actors View details