Alinity 07P4540

Alinity 07P4540 is a Class II device made by Abbott, cleared under FDA 510(k) K210596 on 19 May 2022 and listed in FDA GUDID since 26 Nov 2022 (UDI-DI 00380740174354), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

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	Number00380740174354 UDI-DI	Date26 Nov 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK210596	Date19 May 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00380740174354
FDA 510(k) database 510(k) number K210596

Across registries

2 registries list this device

FDA 510(k) K210596 decided 19 May 2022 Active
FDA GUDID UDI-DI 00380740174354 listed 26 Nov 2022 Listed

Timeline

2 dated events

19 May 2022 Cleared FDA 510(k) K210596
26 Nov 2022 Listed FDA GUDID 00380740174354

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Alinity
Generic name: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog: 07P4540

Primary DI / UDI-DI: 00380740174354
510(k) Number: K210596
FDA product code: LGD
GMDN term: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Device class: Class II
Regulation number: 866.3780
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)