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K-ASSAY® UIBC Reagent KAI-305

by Kamiya Biomedical Company, LLC

Ref KAI-305

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00816426021594 Basic UDI-DI 00816426021594UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816426021594 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
K-Assay Uibc EUDAMED
K-ASSAY® UIBC Reagent GUDID
Generic Name
Unsaturated iron binding capacity (UIBC) IVD, reagent
Device Name
UIBC Reagent
Model / Ref / Catalog
KAI-305
Primary DI / UDI-DI
00816426021594
Basic UDI-DI
B-00816426021594
FDA Product Code
JMO
EMDN Code
W0102070107 Iron binding capacity - total (ic)
GMDN Term
Unsaturated iron binding capacity (UIBC) IVD, reagent
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1415
EU 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 I

Other devices from Kamiya Biomedical Company, LLC

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Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal 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
  • Serial Number: No
  • Manufacturing Date: No