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MicroScan Rapid Yeast ID Panel

by Beckman Coulter Inc.

Ref B1017-70

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number15099501MCRYIDKV Basic UDI-DI 15099590658106UDI-DIDate13 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590658106 UDI-DI Date5 Dec 2022ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
MicroScan Rapid Yeast ID Panel EUDAMED
MicroScan GUDID
Generic Name
Multiple Candida/yeast species culture isolate identification IVD, kit
Model / Reference
B1017-70
Primary DI / UDI-DI
15099590658106
Basic UDI-DI
15099501MCRYIDKV
Unit of Use DI
05099590658109
510(k) Number
FDA Product Code
JXB
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN Term
Multiple Candida/yeast species culture isolate identification IVD, kit
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.2660
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

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

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Properties

  • Single Use
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No