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Alinity 04W2112

by Abbott Ireland Diagnostics

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00380740213909 UDI-DI Date14 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Alinity
Generic Name
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Model / Ref / Catalog
04W2112
Primary DI / UDI-DI
00380740213909
510(k) Number
FDA Product Code
MYF
GMDN Term
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Device Class
Class II
Regulation Number
866.3305
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243575)

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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