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Pr 4100 91587

by Bio-Rad

Ref 91587

Pr 4100 91587 is a device classified as Class A in the EU and Class I in the US made by Bio-Rad, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 361052A000467T) and listed in FDA GUDID since 3 Feb 2023 (UDI-DI 03610520013571), active as of 25 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A000467T Basic UDI-DI 03610520013571UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610520013571 UDI-DI Date3 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361052A000467T registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 03610520013571 listed 3 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03610520013571
  2. Registered EUDAMED 361052A000467T

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  • Withdrawn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
Pr 4100
Generic name
Enzyme immunoassay (EIA) analyser IVD
Device name
Microplate Reader
Model / Ref / Catalog
91587
Primary DI / UDI-DI
03610520013571
Basic UDI-DI
361052A000467T
FDA product code
JJQ
EMDN code
W0204 Infectious immunology instruments
GMDN term
Enzyme immunoassay (EIA) analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2300
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Enzyme immunoassay (EIA) analyser IVD

Similar devices in this category

Other devices filed under INFECTIOUS IMMUNOLOGY INSTRUMENTS.

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Properties

  • Professional testing
  • IVD instrument
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)