Skip to content

MicroScan 40% Potassium Hydroxide 30 ml

by Beckman Coulter Inc. EUDAMEDGUDID

Active European Union

Ref B1010-43A

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15099590655228 UDI-DIDate15 Nov 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number15099501MCRGNTJJ Basic UDI-DIDate11 Feb 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR 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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MicroScan 40% Potassium Hydroxide 30 ml EUDAMED
MicroScan GUDID
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Device Name
MicroScan Reagent Family
Model / Reference
B1010-43A
Primary DI / UDI-DI
15099590655228
Basic UDI-DI
15099501MCRGNTJJ
FDA Product Code
LQM
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN Term
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
866.2660
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No