Architect 04T0420

by Abbott Ireland

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

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00380740180720 UDI-DI	Date24 Oct 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Architect
Generic Name: Lipase IVD, kit, spectrophotometry
Model / Ref / Catalog: 04T0420

Primary DI / UDI-DI: 00380740180720
FDA Product Code: CHI
GMDN Term: Lipase IVD, kit, spectrophotometry

Device Class: Class I
Regulation Number: 862.1465
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (9)

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