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Immunoglobulin Isotypes (GAM) for the EXENT® Analyser

by The Binding Site Group Ltd

Ref MSR801.M

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K250159; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250159↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK250159 Date17 Oct 2025IssuedStatusActive
European UnionCE/IVDR EUDAMED Number5051700MSR801.MJ4 Basic UDI-DI 05051700020701UDI-DIDate30 Aug 2023RegisteredStatusActive

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-2362-2026 FDA Class II initiated 16 Apr 2026 on shared 510(k) K250159

    It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k)

Model / Reference
MSR801.M
Primary DI / UDI-DI
05051700020701
Basic UDI-DI
5051700MSR801.MJ4
EMDN Code
W0102010101, W0102010105, W0102010107, W0102010109
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000036707
Authorised representative
The Binding Site Ireland Limited IE-AR-000034426

Other devices from The Binding Site Group Ltd.

See all devices from The Binding Site Group Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No