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Liquichek 641

by Bio-Rad Laboratories

Ref 641

Liquichek 641 is a multiple lipid analyte IVD (EU IVDR Class C; FDA Class I; FDA product code JJY, Multi-analyte controls, all kinds (assayed)) made by Bio-Rad Laboratories, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 361052A000988E), cleared under FDA 510(k) K012513 on 29 Aug 2001 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661001249), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K012513

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A000988E Basic UDI-DI 00847661001249UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847661001249 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK012513 Date29 Aug 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 361052A000988E registered 6 Nov 2026 Active
  • FDA 510(k) K012513 decided 29 Aug 2001 Active
  • FDA GUDID UDI-DI 00847661001249 listed 14 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K012513
  2. Listed FDA GUDID 00847661001249
  3. Registered EUDAMED 361052A000988E

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  • Withdrawn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
Liquichek Lipids Control Level 1 EUDAMED
Liquichek GUDID
Generic name
Multiple lipid analyte IVD, control
Model / Ref / Catalog
641
Primary DI / UDI-DI
00847661001249
Basic UDI-DI
361052A000988E
510(k) Number
FDA product code
JJY
EMDN code
W0101050202 Lipid controls
GMDN term
Multiple lipid analyte IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
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 C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Multiple lipid analyte IVD, control

Cleared under the same submission (K012513)

Similar devices in this category

Other devices filed under LIPID CONTROLS.

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)