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Anti-Cyclic Citrullinated Peptide Antibody Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581238
Basic UDI-DI: 697518250P115086K
Reference: P11508
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764678
Basic UDI-DI: 697134876029C267437
Reference: MF-029-25
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

PROFAR STREP A TEST

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801060NQ
Basic UDI-DI: B-801060NQ
Reference: 801060-1
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

CRP-ULTRA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673940126
Basic UDI-DI: B-08431673940126
Reference: MD43134
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

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ASO-TURBI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673940065
Basic UDI-DI: B-08431673940065
Reference: MD1107110
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

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RF-TURBI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673940058
Basic UDI-DI: B-08431673940058
Reference: MD1107105
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

Manufacturer products View details

CRP-TURBI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673940041
Basic UDI-DI: B-08431673940041
Reference: MD1107101
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

Manufacturer products View details

CRP-ULTRA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673431341
Basic UDI-DI: B-08431673431341
Reference: 43134
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

Manufacturer products View details

RF-TURBI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673370053
Basic UDI-DI: B-08431673370053
Reference: TK1107005
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

Manufacturer products View details

ASO-TURBI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673371012
Basic UDI-DI: B-08431673371012
Reference: TK1107010
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 23:25

Manufacturer products View details

IMMULITE 2000 High Sensitivity CRP

IVDR_67_LLB_DUB-C_C_REAG_KIT_High Sensitivity CRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961200
Basic UDI-DI: 0405686900226UX
Reference: 10381043
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

STREP A RAPID TEST

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800060-10PZN
Basic UDI-DI: B-800060-10PZN
Reference: 800060-10P
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex Slide

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 805361772044329
Basic UDI-DI: B-805361772044329
Reference: RT1013
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 11:58

Manufacturer products View details

SAA Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308518
Basic UDI-DI: B-69743840308518
Reference: 3051401
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Semi-Quantitative Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303322
Basic UDI-DI: B-69743840303322
Reference: 3050701
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor (RF)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182720070
Basic UDI-DI: B-62230182720070
Reference: D-838 002
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor (RF)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182719944
Basic UDI-DI: B-62230182719944
Reference: D-838 001
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor (RF)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182719876
Basic UDI-DI: B-62230182719876
Reference: D-838 000
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor (RF) Turbi Latex

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182719326
Basic UDI-DI: B-62230182719326
Reference: D-853 001
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

C Reactive Protein (CRP) Turbi Latex

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182718640
Basic UDI-DI: B-62230182718640
Reference: D-852 001
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details