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D-10 Dual 220-0201

by Bio-Rad Laboratories

Ref 2200201

D-10 Dual 220-0201 (2200201) 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 14 Oct 2026 (Basic UDI-DI 361052A004768Q), cleared under FDA 510(k) K041444 on 9 Jun 2004 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817000096), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K041444

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A004768Q Basic UDI-DI 00847817000096UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847817000096 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK041444 Date9 Jun 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 361052A004768Q registered 14 Oct 2026 Active
  • FDA 510(k) K041444 decided 9 Jun 2004 Active
  • FDA GUDID UDI-DI 00847817000096 listed 12 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2889-2011 FDA Unclassified (pre-2012) initiated 11 Jul 2011

    Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.

    • Terminated Z-0376-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006 on shared 510(k) K041444

    The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K041444
  2. Recall initiated FDA recalls Z-0376-2007
  3. Recall initiated FDA recalls Z-2889-2011
  4. Listed FDA GUDID 00847817000096
  5. Registered EUDAMED 361052A004768Q

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
D-10 Dual Program Reorder Pack EUDAMED
D-10 Dual GUDID
Generic name
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Device name
D-10 Dual Program
Model / Ref / Catalog
2200201, 220-0201
Primary DI / UDI-DI
00847817000096
Basic UDI-DI
361052A004768Q
510(k) Number
FDA product code
JPD, LCP
EMDN code
W0103010202, W0106010204
GMDN term
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Device class
Class C EUDAMED
Class II GUDID
Regulation number
864.7400, 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
2200201
GUDID
220-0201
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, kit, liquid chromatographyInherited haemoglobinopathy IVD, kit, liquid chromatography

Cleared under the same submission (K041444)

and 5 more cleared under K041444

Similar devices in this category

Other devices filed under HAEMOGLOBIN (TYPES) TESTING.

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Contains latex
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)