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Normal Range Trace Elements 66816

by UTAK Laboratories Inc.

Ref 66816

Normal Range Trace Elements 66816 is a multiple heavy metal IVD (EU IVDD general IVD; FDA Class I; FDA product code JJY, Multi-Analyte Controls, All Kinds (Assayed)) made by UTAK Laboratories Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-B800668160) and listed in FDA GUDID since 15 Apr 2020 (UDI-DI B800668160), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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/IVDD EUDAMED NumberB-B800668160 Basic UDI-DI B800668160UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB800668160 UDI-DI Date15 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B800668160 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI B800668160 listed 15 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B800668160
  2. Registered EUDAMED B-B800668160

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
NR Trace Elements EUDAMED
Normal Range Trace Elements GUDID
Generic name
Multiple heavy metal IVD, control
Model / Ref / Catalog
66816
Primary DI / UDI-DI
B800668160
Basic UDI-DI
B-B800668160
FDA product code
JJY
EMDN code
W0101050102 Unassayed multicomponent controls (cc)
GMDN term
Multiple heavy metal IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General 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 heavy metal IVD, control

Similar devices in this category

Other devices filed under UNASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from UTAK Laboratories Inc.

See all devices from UTAK Laboratories Inc. →

Properties

  • Contains human tissues or cells
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)