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Rheumatoid Factor CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224858
Basic UDI-DI: B-06975424224858
Reference: CL20191E
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, RF IgG

RF IgG, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403461
Basic UDI-DI: B-06924030403461
Reference: MY00231
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

ACCENT-200 RF

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514672370
Basic UDI-DI: B-05907514672370
Reference: 7-237
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 14:00

Manufacturer products View details

CRP XL Wide range

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168006262
Basic UDI-DI: B-05415168006262
Reference: CPTXL-L00/ALI
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

CRP XL Wide range

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168006255
Basic UDI-DI: B-05415168006255
Reference: CPTXL-H00/ALI
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

Atlas CRP Latex Kit, 100 Tests (4ml Latex, 1x0.5ml Positive Control, 1x0.5ml Negative Control, 1x10ml Buffer (20X), Glass Slide, Stirring Sticks).

8.00.01.4.0100

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04262408510086
Basic UDI-DI: B-04262408510086
Reference: 8.00.01.4.0100
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:43

Manufacturer products View details

Diagnostic Kit for C-reactive Protein

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315724
Basic UDI-DI: B-04260163315724
Reference: 07CRP5025
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

AESKULISA® CCP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503372
Basic UDI-DI: B-04250289503372
Reference: 3166
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® RA/CP-Detect

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500814
Basic UDI-DI: B-04250289500814
Reference: 3165
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Rf-AGM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500777
Basic UDI-DI: B-04250289500777
Reference: 3161
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Rf-Check

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500760
Basic UDI-DI: B-04250289500760
Reference: 3160
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Sclero-Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500609
Basic UDI-DI: B-04250289500609
Reference: 3121
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45ml, R2: 1x15ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238079
Basic UDI-DI: B-06942202238079
Reference: 3011468
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45ml, R2: 1x15ml, Calibration sample: 2x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238086
Basic UDI-DI: B-06942202238086
Reference: 3011799
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50ml, R2: 1x10ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239489
Basic UDI-DI: B-06942202239489
Reference: 3011837
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50ml, R2: 1x10ml, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239458
Basic UDI-DI: B-06942202239458
Reference: 3011415
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238703
Basic UDI-DI: B-06942202238703
Reference: 3014556
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 2x60ml, R2: 2x15ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202240997
Basic UDI-DI: B-06942202240997
Reference: 3012486
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 2x60ml, R2: 2x15ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239687
Basic UDI-DI: B-06942202239687
Reference: 3014557
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CRP LATEX

LXCR-0112

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700829379
Basic UDI-DI: B-03701700829379
Reference: LXCR-0112
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details