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IgG FITC

by Biosystems S.A.

Ref 44838, 56252, 50380, 50379, 12012272

IgG FITC (44838) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category immunochemistry reagents) made by Biosystems S.A., registered in EUDAMED on 22 Oct 2025 (Basic UDI-DI B-08435287104318), active as of 22 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08435287104318 Basic UDI-DI Date22 Oct 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
IgG FITC
IgG FITC/EVANS (M)
IgG FITC/EVANS
IgG FITC/EVANS (M) hs
Model / reference
44838, 56252, 50380, 50379, 12012272
Primary DI / UDI-DI
08435287104318, 08012992562529, 08012992503805, 08012992503799, 03610522158256
Basic UDI-DI
B-08435287104318, B-08012992562529, B-08012992503805, B-08012992503799, B-03610522158256
EMDN code
W01029099 Immunochemistry reagents - other
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

Similar devices in this category

Other devices filed under IMMUNOCHEMISTRY REAGENTS - OTHER.

Other devices from Biosystems S.A.

See all devices from Biosystems S.A. →

Properties

  • Contains human tissues or cells YesEUDAMEDNoEUDAMED
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)