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C-Reactive Protein Latex

EUDAMED

Class IVD General (EU MDR)

Ref B21531Model C-Reactive Protein [CRP] Latex 360 mL

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

Identity

Trade Name
C-Reactive Protein Latex EUDAMED
Device Name
C-Reactive Protein [CRP] Latex EUDAMED
Model / Reference
C-Reactive Protein [CRP] Latex 360 mL EUDAMED
B21531 EUDAMED

Identifiers

Primary DI / UDI-DI
08683555610911 EUDAMED
Basic UDI-DI
B-08683555610911 EUDAMED
EMDN Code
W01021109 C-REACTIVE PROTEIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

C-Reactive Protein Latex by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
EUDAMED SRN
TR-MF-000040334

Sources (1)

  • EUDAMED 7d42fd2d-2955-4e36-ba61-e3cb5665de27 61 fields · synced Oct 6, 2026