Architect 06R8620

by Abbott Laboratories

Architect 06R8620 is a device classified as Not classified made by Abbott Laboratories, listed in FDA GUDID since 30 May 2020 (UDI-DI 00380740191832), 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	Number00380740191832 UDI-DI	Date30 May 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00380740191832

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Architect
Generic name: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog: 06R8620

Primary DI / UDI-DI: 00380740191832
FDA product code: QKO
GMDN term: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Device class: N
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Premarket exempt
Lot / batch number
Expiration date

Other properties (10, all answered No)