Alinity 07P5121

by Abbott Ireland

Alinity 07P5121 is a Class II device made by Abbott Ireland, listed in FDA GUDID since 31 May 2018 (UDI-DI 00380740160616), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00380740160616 UDI-DI	Date31 May 2018Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00380740160616

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Alinity
Generic name: Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog: 07P5121

Primary DI / UDI-DI: 00380740160616
FDA product code: DHA
GMDN term: Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay

Device class: Class II
Regulation number: 862.1155
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (11, all answered No)