Alinity 04T961A
by Abbott
Alinity 04T961A is a Class I device made by Abbott, listed in FDA GUDID since 14 Jun 2022 (UDI-DI 00380740186265), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00380740186265 | Date14 Jun 2022 | StatusListed |
Official records
- AccessGUDID record 00380740186265
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Alinity
- Generic name
- Laboratory instrument/analyser application software IVD
- Model / Ref / Catalog
- 04T961A
- Primary DI / UDI-DI
- 00380740186265
- FDA product code
- JJE
- GMDN term
- Laboratory instrument/analyser application software IVD
- Device class
- Class I
- Regulation number
- 862.2160
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Laboratory instrument/analyser application software IVD.
- SecurView DX Manager SVDX Manager SVDX-00600-HIRES by Hologic
- AlinIQ 03R89-62 03R8962 by ABBOTT S.r.l.
- AlinIQ 03R8967 by ABBOTT S.r.l.
- Ion Torrent Genexus Dx Software 6.8 A56332 by Life Technologies Holdings Pte Ltd.
- EUROLabOffice 4.0 YG 0250-0101-7 by EUROIMMUN Medizinische Labordiagnostika AG
- EUROPicture YG 0011-0101 by EUROIMMUN Medizinische Labordiagnostika AG
- Ortho Connect 3.0 by BIOMEDICAL DATA SOLUTIONS LIMITED
- iQ®200 Body Fluids Module 800-3704 by BECKMAN COULTER IRELAND INC.
- ARCHITECT c ACE Assay File 6U82-1A by Sentinel Ch. Srl
- SecurView Diagnostic Workstation SecurView DX by Hologic