Skip to content

Pastorex 56353

by Bio-Rad

Ref 56353

Pastorex 56353 is a device classified as Class B in the EU and Class I in the US made by Bio-Rad, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 361052A000147E) and listed in FDA GUDID since 22 Dec 2022 (UDI-DI 03610520000953), 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 Number361052A000147E Basic UDI-DI 03610520000953UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610520000953 UDI-DI Date22 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361052A000147E registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 03610520000953 listed 22 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03610520000953
  2. Registered EUDAMED 361052A000147E

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  • Withdrawn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
Pastorex Staph-Plus EUDAMED
Pastorex GUDID
Generic name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Device name
Agglutination test Staph
Model / Ref / Catalog
56353
Primary DI / UDI-DI
03610520000953
Basic UDI-DI
361052A000147E
FDA product code
LHJ
EMDN code
W0105011201 Staphylococcal direct antigen detection
GMDN term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.3700
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 B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

Similar devices in this category

Other devices filed under STAPHYLOCOCCI.

Other devices from Bio-Rad

See all devices from Bio-Rad →

Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)