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K-ASSAY® CRP Reagent (Ver.2) KAI-375

by Kamiya Biomedical Company, LLC EUDAMEDGUDID

Active European Union

Ref KAI-375

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00816426021549 Basic UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816426021549 UDI-DIDate27 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
K-ASSAY CRP (Ver.2) EUDAMED
K-ASSAY® CRP Reagent (Ver.2) GUDID
Generic Name
C-reactive protein (CRP) IVD, reagent
Device Name
CRP (Ver.2) Reagent
Model / Ref / Catalog
KAI-375
Primary DI / UDI-DI
00816426021549
Basic UDI-DI
B-00816426021549
510(k) Number
FDA Product Code
DCK
EMDN Code
W01021109 C-reactive protein
GMDN Term
C-reactive protein (CRP) IVD, reagent
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5270
Market of Registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No