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Atellica Im Elf Mcm Set 11208708

by Siemens Healthcare Diagnostics Inc.

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 Number00630414618111 UDI-DI Date15 Mar 2023ListedStatusListed 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  • Withdrawn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
Atellica Im Elf Mcm Set
Generic Name
Multiple liver fibrosis marker IVD, control
Model / Ref / Catalog
11208708
Primary DI / UDI-DI
00630414618111
FDA Product Code
JJX
GMDN Term
Multiple liver fibrosis marker IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple liver fibrosis marker IVD, control

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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