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D-100 290-1011

by Bio-Rad Laboratories

Part of a family of 7 devices: see the family page

Ref 2901011

D-100 290-1011 (2901011) is a device classified as Class C in the EU and Class II in the US made by Bio-Rad Laboratories, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 361052A004728G) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817016028), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A004728G Basic UDI-DI 00847817016028UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847817016028 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361052A004728G registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00847817016028 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847817016028
  2. Registered EUDAMED 361052A004728G

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  • Withdrawn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
D-100 HbA1c Elution Buffer B EUDAMED
D-100 GUDID
Generic name
Glycated haemoglobin (HbA1c) IVD, reagent
Device name
D-100 HbA1C
Model / Ref / Catalog
2901011, 290-1011
Primary DI / UDI-DI
00847817016028
Basic UDI-DI
361052A004728G
FDA product code
PDJ, LCP
EMDN code
W0106010204 Diabetes
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1373, 864.7470
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2901011
GUDID
290-1011
Device classEUDAMED
Class C
GUDID
Class II

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

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Similar devices in this category

Other devices filed under POLYGENETIC DISORDERS.

Other devices from Bio-Rad Laboratories

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Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)