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Atellica CH Acetaminophen (AcetC) 11701323

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00630414654164 UDI-DI Date15 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2416-2015 FDA Class II initiated 30 Jun 2015

    A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Atellica CH Acetaminophen (AcetC)
Generic Name
Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
11701323
Primary DI / UDI-DI
00630414654164
510(k) Number
FDA Product Code
LDP
GMDN Term
Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.3030
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K100200)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No