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EliA CTD 13 Screen Well DECC066610

by Phadia GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07333066021379 UDI-DI Date10 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EliA CTD 13 Screen Well
Generic Name
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
DECC066610
Primary DI / UDI-DI
07333066021379
FDA Product Code
LLL
GMDN Term
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Device Class
Class II
Regulation Number
866.5100
GUDID distribution status
In Commercial Distribution

Other devices from Phadia GmbH

See all devices from Phadia GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No