Rals 8.4.0

by Abbott Rapid Diagnostics Informatics, Inc.

Rals 8.4.0 is a Class I device made by Abbott Rapid Diagnostics Informatics, Inc., listed in FDA GUDID since 4 Oct 2024 (UDI-DI 00850049633246), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850049633246 UDI-DI	Date4 Oct 2024Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00850049633246

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Rals
Generic name: Medical equipment clinical data interfacing software
Model / Ref / Catalog: 8.4.0

Primary DI / UDI-DI: 00850049633246
FDA product code: JQP
GMDN term: Medical equipment clinical data interfacing software

Device class: Class I
Regulation number: 862.2100
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Medical equipment clinical data interfacing software.

Other devices from Abbott Rapid Diagnostics Informatics, Inc.

Rals 7.1.2

Class I
Rals 8.4.1

Class I
Rals 7.1.4

Class I
Rals 7.1.3

Class I

See all devices from Abbott Rapid Diagnostics Informatics, Inc. →

Properties

Premarket exempt
Lot / batch number

Other properties (13, all answered No)