Architect 08K2529

Architect 08K2529 is a Class II device made by Abbott, listed in FDA GUDID since 3 Mar 2020 (UDI-DI 00380740156244), 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	Number00380740156244 UDI-DI	Date3 Mar 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00380740156244

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Architect
Generic name: Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog: 08K2529

Primary DI / UDI-DI: 00380740156244
FDA product code: CEW
GMDN term: Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Device class: Class II
Regulation number: 862.1545
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)