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Total Protein

by Beckman Coulter Inc. 3 variants

Ref OSR6132

Total Protein (OSR6132) is a device classified as Class B in the EU and Class II in the US made by Beckman Coulter, Inc., registered in EUDAMED on 16 Jun 2022 (Basic UDI-DI 150995901OSR6132LY) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 15099590010294), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901OSR6132LY Basic UDI-DI 15099590010294UDI-DIDate16 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590010294 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 150995901OSR6132LY registered 16 Jun 2022 Active
  • FDA GUDID UDI-DI 15099590010294 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15099590010294
  2. Registered EUDAMED 150995901OSR6132LY

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  • Withdrawn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
Total Protein EUDAMED
Au GUDID
Generic name
Total protein IVD, kit, enzyme spectrophotometry
Model / reference
OSR6132
Primary DI / UDI-DI
15099590010294
Basic UDI-DI
150995901OSR6132LY
FDA product code
CEK
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Total protein IVD, kit, enzyme spectrophotometry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1635
EU registration type
Standard device
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 II

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

Manufacturer details

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

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)